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FDA Approval Activities for this Drug…
| Famotidine Injection, 10 mg/mL, Apotex Corp. ANDA 76-324 11/27/02 | Famotidine Injection, 10 mg/mL, Apotex Corp. ANDA 76-322 11/27/02 | Famotidine Injection, 10 mg/mL, 4mL & 20 mL vials, Apotex Corp. ANDA 75-942 8/2/02 | Famotidine Injection, 10 mg/mL, Abbott ANDA 75-905 11/23/01 4/17/03 | Famotidine Injection, 10 mg/mL, Abbott ANDA 75-870 11/23/01 4/17/03 | Famotidine Injection, 10 mg/mL, Ben Venue, ANDA 75-825 4/17/01 4/24/01 | Famotidine Injection, 10 mg/mL (Preservative-Free), 1/25/2001 Ben Venue, ANDA 75-825 1/25/01 3/5/01 | Famotidine Injection, 10 mg/mL, American Pharmaceutical Partners, ANDA 75-813 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL (4 mL and 20 mL Multi-dose vials, Baxter Pharmaceutical Products ANDA 75-799 4/30/02 | Famotidine Injection (Preservative Free, 10 mg/mL (2 mL vial, Baxter HealthCare ANDA 75-789 4/30/02 | Famotidine Injection, 0.4 mg/mL & 50 mL, Abbott ANDA 75-729 12/17/01 | Famotidine Injection, 10 mg/mL & 20 mL, American Pharmaceutical Partners, ANDA 75-709 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL & 20 mL, American Pharmaceutical Partners, ANDA 75-709 2/28/01 3/6/01 | Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-708 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-708 2/7/01 3/6/01 | Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-707 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, Apothecon ANDA 75-707 3/13/01 3/30/01 | Famotidine Injection, 10 mg/mL, Faulding Pharmaceutical Co. ANDA 75-705 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, 12/12/2000 Faulding Pharmaceutical Co. ANDA 75-705 12/12/00 3/5/01 | Famotidine Injection, 10 mg/mL, Bedford ANDA 75-684 4/16/01 4/24/01 12/17/01 | Famotidine Injection, 10 mg/mL, 1/24/2001 Bedford ANDA 75-684 1/24/01 3/5/01 | Famotidine Injection, 10 mg/mL (Preservative-Free), Faulding Pharmaceutical Co. ANDA 75-669 4/16/01 4/24/01 12/17/01 | Famotidine Injection, 10 mg/mL (Preservative-Free), 12/12/2000 Faulding Pharmaceutical Co. ANDA 75-669 12/12/00 3/5/01 | Famotidine Injection, 10 mg/mL, (Preservative Free), Bedford ANDA 75-651 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, (Preservative Free), Bedford ANDA 75-622 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, (Preservative Free), 12/26/2000 Bedford ANDA 75-622 12/26/00 3/5/01 | Famotidine Injection, 0.4 mg/mL (20 mg/50 mL), Baxter Healthcare Corp. ANDA 75-591 5/10/01 6/5/01 | Famotidine Injection, 10 mg/mL, 4 mL and 20 mL multiple-dose vials (Preserved), ESI Lederle ANDA 75-488 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, 4 mL and 20 mL multiple-dose vials (Preserved), 12/20/2000 ESI Lederle ANDA 75-488 12/20/00 3/5/01 | Famotidine Injection, 10 mg/mL, 2 mL vials (Preservative-Free), ESI Lederle ANDA 75-486 4/16/01 4/24/01 | Famotidine Injection, 10 mg/mL, 2 mL vials (Preservative-Free) 12/20/2000 ESI Lederle ANDA 75-486 12/20/00 3/5/01 | Famotidine Injection, 10 mg/mL, 2 mL vial (Preservative-Free) 11/20/1998 Marsam ANDA 75-194 11/20/98 11/20/98 | Famotidine Injection,10 mg/mL, Pharmacy bulk package (Preservative-Free), Nov. 30, 1998 Marsam ANDA 75-193 11/30/98 12/1/98 | Famotidine Injection, 10 mg/mL, 4 mL and 20 mL Multiple-Dose Vials 11/20/1998 Marsam ANDA 75-192 11/20/98 11/20/98 | Famotidine Tablets USP, 10 mg, OTC Eon labs ANDA 76-101 10/21/02 | Famotidine Tablets USP, 10 mg, Eon labs Manufacturing, ANDA 76-101 9/14/01 4/16/03 | Famotidine Tablets USP,20 & 40 mg, Carlsbad Technology ANDA 75-805 4/16/01 4/24/01 | Famotidine Tablets USP,20 & 40 mg, Eon Labs Manufacturing, ANDA 75-793 4/16/01 4/24/01 | Famotidine Tablets USP, 20 mg and 40 mg, Wockhardt Americas, ANDA 75-786 4/16/01 4/24/01 | Famotidine Tablets USP, 20 mg and 40 mg, 3/28/01 Wockhardt Americas, ANDA 75-786 3/28/01 3/30/01 | Famotidine Tablets USP, 10 mg, OTC Dr. Reddy's Ltd. ANDA 75-758 8/17/01 | Famotidine Tablets USP, 10 mg, OTC 12/13/00 Cheminor Drugs Limited ANDA 75-758 12/13/00 3/5/01 | Famotidine Tablets USP,20 mg and 40 mg, 11/29/00 Cheminor Drugs Limited ANDA 75-718 11/29/00 3/5/01 | Famotidine Tablets USP,20 mg and 40 mg, Reddy-Cheminor ANDA 75-718 4/16/01 4/24/01 | Famotidine Tablets USP,20 mg and 40 mg, 7/27/00 Reddy-Cheminor ANDA 75-718 7/27/00 11/7/00 | Famotidine Tablets USP, 10 mg, L.Perrigo Company ANDA 75-715 8/22/03 | Famotidine Tablets USP,20 mg and 40 mg, Mylan ANDA 75-704 4/16/01 4/24/01 | Famotidine Tablets USP,20 mg and 40 mg, 2/6/2001 Mylan ANDA 75-704 2/6/01 3/5/01 | Famotidine Tablets USP, 10 mg, OTC Genpharm ANDA 75-674 12/21/01 | Famotidine Tablets USP, 10 mg, OTC Genpharm ANDA 75-674 10/12/01 | Famotidine Tablets USP, 20 mg and 40 mg, Purepac Pharmaceutical Co. ANDA 75-650 9/14/01 4/14/03 5/1/02 5/1/02 | Famotidine Tablets USP,20 mg and 40 mg, 3/17/2000 Purepac Pharmaceutical Co. ANDA 75-650 3/17/00 3/21/00 | Famotidine Tablets USP, 20 mg & 40 mg, Mutual Pharmaceutical Company, ANDA 75-639 12/12/01 | Famotidine Tablets USP,20 mg & 40 mg, (tentatively Approved 3/16/00) Apothecon, ANDA 75-628 3/16/00 3/21/00 | Famotidine Tablets USP, 10 mg, Torpharm ANDA 75-610 3/12/02 4/10/03 | Famotidine Tablets USP, 20 mg and 40 mg, Invamed ANDA 75-607 5/10/01 6/5/01 | Famotidine Tablets USP, 20 mg and 40 mg, Torpharm ANDA 75-611 7/23/01 | Famotidine Tablets USP, 20 mg and 40 mg, Zenith Goldline ANDA 75-511 4/16/01 4/24/01 | Famotidine Tablets USP, 20 mg and 40 mg, February 18, 2000 Zenith Goldline ANDA 75-511 2/18/00 | Famotidine Tablets USP, 20 mg & 40 mg, Genpharm ANDA 75-457 4/18/01 4/24/01 | Famotidine Tablets USP, 20 mg & 40 mg, 4/26/2000 Genpharm ANDA 75-457 4/26/00 4/28/00 | Famotidine Tablets USP, 10 mg, Danbury Pharmacal, ANDA 75-404 11/28/01 4/14/03 | Famotidine Tablets USP, 10 mg, Jun. 04, 1999 Danbury Pharmacal, ANDA 75-404 6/4/99 6/11/99 | Famotidine Tablets USP, 10 mg, L. Perrigo Co. ANDA 75-400 3/25/02 4/10/03 | Famotidine Tablets USP, 10 mg, Teva ANDA 75-312 5/31/01 6/5/01 | Famotidine Tablets USP, 10 mg, 10/15/1998 Teva ANDA 75-312 10/15/98 10/26/98 | Famotidine Tablets USP, 20 mg and 40 mg, Teva ANDA 75-311 4/16/01 4/24/01 1/3/02 1/3/02 | Famotidine Tablets USP, 20 mg and 40 mg, Oct. 15, 1998 Teva ANDA 75-311 10/15/98 10/26/98 | Famotidine Tablets USP, 20 mg and 40 mg, Geneva ANDA 75-302 4/16/01 4/24/01 | Famotidine Tablets USP, 20 mg and 40 mg, Geneva ANDA 75-302 2/5/01 2/28/01 | Famotidine Tablets USP, 20 mg and 40 mg, Geneva ANDA 75-302 8/30/99 9/2/99 | Famotidine Tablets USP, 20 mg and 40 mg,Rx Danbury Pharmacal ANDA 75-062 4/16/01 4/24/01 | Famotidine Tablets USP, 20 mg and 40 mg,Rx , 10/28/1998 Danbury Pharmacal ANDA 75-062 10/28/98 10/28/98 | Famotidine Tablets USP, 20 mg and 40 mg, October 28, 1998 Novopharm Limited ANDA 74-687 10/28/98 10/29/98 Pepcid AC Coated Tablets,10 mg, OTC Merck & Co., Inc NDA 19-462 4/30/03 | Pepcid AC Coated Tablets,10 mg, OTC Merck & Co., Inc NDA 19-462/S29 4/25/01 4/23/03 | Pepcid Complete Chewable Tablets, Suspension, Orally Disintegrating Tablets Merck & Co., Inc NDA 19-510 11/4/86 4/30/03 | Pepcid AC Coated Tablets,10 mg, OTC Merch Research NDA 20-902 8/5/99 5/16/00 | Pepcid AC (Famotidine) Tablets, Merck & Co., NDA 20-325/S15 9/23/03 9/30/03 9/30/03 | Pepcid AC Film Coated Tablets, Merck & Co., NDA 20-325/S-013 3/1/02 3/5/02 | Pepcid AC Film Coated Tablets, Merck & Co., NDA 20-325/S-3 3/1/02 3/6/02 | Pepcid AC (famotidine) Chewable Tablets, OTC Merck & Co., NDA 20-801/S-007 1/31/02 3/6/02 | Pepcid AC Chewable Tablets, OTC Merck Reseach NDA 20-801/S-004 4/10/01 4/9/03 5/9/03 | Pepcid AC (famotidine) Chewable Tablets,OTC Merck Reseach NDA 20-801 9/24/98 9/25/98 9/25/98 3/16/99 | Pepcid AC Indications:1) For the relief of heartburn, acid indigestion, and sour stomach. 2) For the prevention of heartburn, acid indigestion, and sour stomach brough on by consuming food and beverages. | Pepcid Complete Chewable Tablets, Suspension, Orally Disintegrating Tablets Merck Research NDA 20-958/S2 11/06/01 04/25/03 | Pepcid Complete Chewable Tablets, OTC Merck Research NDA 20-958 10/16/00 10/20/00 10/30/00 9/25/03 | Pepcid Indication:for use in the relief of heartburn associated with acid indigestion and sour stomach. | Pepcid (Famotidine) Coated (gelatin coated, capsule shaped) Tablets Merck Research NDA 20-752 8/5/99 8/6/99 8/6/99 Pepcid Indication:1. Treatment of Heartburn associated with acid indigestion and sour stomach 2. Prevention of meal-induced heartburn | Pepcid (Famotidine) RPD Orally Disintegrating Tablets,20 and 40 mg Merck Research NDA 20-752 5/28/98 6/1/98 6/1/98 Pepcid RPD Indication:This application provides for a new dosage form for prescription | Pepcid (Famotidine) which is indicated for the treatment of ulcers, GERD, and hypersecretory disease (see labeling for details). | Pepcid (Famotidine) Coated (gelatin coated, capsule shaped) Tablets Merck Research NDA 20-752 8/5/99 Pepcid Indication:1. Treatment of Heartburn associated with acid indigestion and sour stomach 2. Prevention of meal-induced heartburn | Pepcid (Famotidine) Tablets, Suspension, Orally Disintegrating Tablets Merck Research NDA 19-462/S31, 19-527/S25, & 20-752/S6 3/14/01 | Pepcid (Famotidine) Tablets, Injection, & Suspension, Merck and Co. NDA 19-462/S30, 19-527/S24, & 20-752/S5 6/6/02 6/14/02 6/7/02 | Pepcid (Famotidine) Tablets, Injection, & Suspension, Merck Research NDA 19-462/S27, 19-527/S20, & 20-752/S2 3/18/99 7/5/00 | Pepcid (Famotidine) Injection & Injection Premixed, Merck Research NDA 19-510/S029 & 20-249/S12 3/14/01 4/27/01 4/27/01 | Pepcid (Famotidine) Injection & Injection Premixed, Merck and Co., NDA 19-510/S028 & 20-249/S011 6/6/02 6/14/02 6/7/02 | Pepcid (Famotidine) Injection & Injection Premixed, Merck Research NDA 19-510/S026 & 20-249/S09 3/18/99 8/17/99 Pepcid Indications: Short term treatment of active duodenal ulcer. FAMOTIDINE For Suspension; 40MG/5ML PEPCID MERCK 075729 | Famotidine Injection 0.4MG/ML FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER Abbott | 075870 Famotidine Injection 10MG/ML FAMOTIDINE Abbott | 075905 Famotidine Injection 10MG/ML FAMOTIDINE Abbott | 075813 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE AM PARTNERS 075709 | Famotidine Injection 10MG/ML FAMOTIDINE AM PARTNERS 076322 | Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK) Apotex | 076324 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Apotex | 075942 Famotidine Injection 10MG/ML FAMOTIDINE Apotex | 075591 Famotidine Injection 0.4MG/ML FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER Baxter | 075486 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Baxter | 075488 | Famotidine Injection 10MG/ML FAMOTIDINE Baxter | 075789 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Baxter | 075799 Famotidine Injection 10MG/ML FAMOTIDINE Baxter | 075622 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Bedford | 075651 Famotidine Injection 10MG/ML FAMOTIDINE Bedford | 075684 Famotidine Injection 10MG/ML FAMOTIDINE Bedford | 075825 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Ben Venue | 075669 Famotidine Injection 10MG/ML FAMOTIDINE PRESERVATIVE FREE Faulding | 075705 Famotidine Injection 10MG/ML FAMOTIDINE Faulding | 020249 Famotidine Injection 0.4MG/ML PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER MERCK 019510 Famotidine Injection 10MG/ML PEPCID MERCK 019510 Famotidine Injection 10MG/ML PEPCID PRESERVATIVE FREE MERCK 075805 FAMOTIDINE Tablet; 20MG FAMOTIDINE CARLSBAD 075805 FAMOTIDINE Tablet; 40MG FAMOTIDINE CARLSBAD 075718 FAMOTIDINE Tablet; 20MG FAMOTIDINE DR REDDYS LTD 075718 FAMOTIDINE Tablet; 40MG FAMOTIDINE DR REDDYS LTD 075793 FAMOTIDINE Tablet; 20MG FAMOTIDINE Eon | 075793 FAMOTIDINE Tablet; 40MG FAMOTIDINE Eon | 075302 FAMOTIDINE Tablet; 20MG FAMOTIDINE Geneva | 075302 FAMOTIDINE Tablet; 40MG FAMOTIDINE Geneva | 075457 FAMOTIDINE Tablet; 20MG FAMOTIDINE Genpharm | 075457 FAMOTIDINE Tablet; 40MG FAMOTIDINE Genpharm | 075607 FAMOTIDINE Tablet; 20MG FAMOTIDINE INVAMED 075607 FAMOTIDINE Tablet; 40MG FAMOTIDINE INVAMED 075511 FAMOTIDINE Tablet; 20MG FAMOTIDINE Ivax | 075511 FAMOTIDINE Tablet; 40MG FAMOTIDINE Ivax | 019462 FAMOTIDINE Tablet; 20MG PEPCID MERCK 019462 FAMOTIDINE Tablet; 40MG PEPCID MERCK 075639 FAMOTIDINE Tablet; 20MG FAMOTIDINE Mutual | 075639 FAMOTIDINE Tablet; 40MG FAMOTIDINE Mutual | 075704 FAMOTIDINE Tablet; 20MG FAMOTIDINE Mylan 075704 FAMOTIDINE Tablet; 40MG FAMOTIDINE Mylan 075650 FAMOTIDINE Tablet; 20MG FAMOTIDINE Purepac | 075650 FAMOTIDINE Tablet; 40MG FAMOTIDINE Purepac | 075311 FAMOTIDINE Tablet; 20MG FAMOTIDINE Teva 075311 FAMOTIDINE Tablet; 40MG FAMOTIDINE Teva 075611 FAMOTIDINE Tablet; 20MG FAMOTIDINE Torpharm 075611 FAMOTIDINE Tablet; 40MG FAMOTIDINE Torpharm 075062 FAMOTIDINE Tablet; 20MG FAMOTIDINE Watson | 075062 FAMOTIDINE Tablet; 40MG FAMOTIDINE Watson | 075786 FAMOTIDINE Tablet; 20MG FAMOTIDINE Wockhardt 075786 FAMOTIDINE Tablet; 40MG FAMOTIDINE Wockhardt Pepcid Complete Tablets, Merck | Famotidine Tablets USP, Teva Pharmaceuticals | Fluxid (famotidine orally disintegrating tablets), Schwarz Pharma, Approval | Pepcid AC Film Coated (famotidine) Tablets, Merck Research, Labeling Revision | Pepcid AC Chewable (famotidine) Tablets, Merck Research, Labeling Revision | Pepcid AC Gelcaps (famotidine) Capsules, Merck Research, Labeling Revision | Pepcid Complete Tablets, Merck Research, Labeling Revision | Pepcid (Famotidine) Oral Suspension, Merck & Co., Labeling Revision | Famotidine Tablets, Wockhardt, Approval | Famotidine Tablets, L. Perrigo Co., Approval | Pepcid Complete chewable tablets, Merck, Labeling Revision | Famotidine Tablets, Perrigo, Approval | Famotidine Tablets, Dr. Reddy's Labs, Tentative Approval | Famotidine Tablets, Perrigo R&D, Tentative Approval | Pepcid AC (famotidine) tablets, Merck & Co., Labeling Revision | Pepcid AC Gelcaps (famotidine) capsules , Merck & Co., Labeling Revision | Pepcid Complete tablets, Merck & Co., Labeling Revision | Famotidine Tablets, Perrigo R&D, Approval | Famotidine Tablets, Dr. Reddy’s Labs, Approval | Pepcid (Famotidine) Oral Suspension, Salix Pharma, Labeling Revision | Pepcid (Famotidine) Tablets, Merck & Co., Labeling Revision | Pepcid (Famotidine) Injection , Merck & Co., Labeling Revision | Pepcid (Famotidine) Injection Premixed, Merck & Co., Labeling Revision | Pepcid AC (famotidine) Chewable Tablet, Merck & Co., New Dosage Regimen | Famotidine, Calcium Carbonate, and Magnesium Hydroxide, Chewable Tablets, Perrigo R&D Co., Approval | Famotidine Injection, Akorn-Strides, LLC, Approval | Famotidine Preservative-Free (famotidine) Injection, Akorn-Strides, LLC, Approval | Pepcid Complete (calcium carbonate, famotidine and magnesium hydroxide) Chewable Tablets, Merck & Co., Inc., Formulation Revision | Famotidine Tablets, L. Perrigo Co., Control Supplement | Famotidine Tablets, Alembic Limited, Approval | Famotidine Tablets, Ranbaxy Laboratories Ltd., Approval | Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision | Famotidine Oral Suspension, Navinta LLC, Approval | Famotidine Oral Suspension, Lupin Ltd., Approval | Famotidine Tablets, Wockhardt Ltd., Approval | Duexis (ibuprofen and famotidine) Tablets, Horizon Pharma, Inc., Approval | Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision
  
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