FDA Approval Activities for this Drug…

IBU (Ibuprofen) Tablets, 400, 600 & 800 mg, BASF ANDA 75-682 11/14/01 4/14/03 Ibuprofen Capsules, 200 mg Banner Pharmacaps, NDA 21-472 10/18/02 10/28/02 Ibuprofen Capsules, 200 mg, OTC Pharmaceutical Formulations ANDA 74-782 7/6/98 7/6/98 3/30/99 Ibuprofen Suspension USP, 100 mg/5 mL, OTC Alpharma ANDA 74-916 1/9/98 3/15/99 Ibuprofen Suspension USP, 100 mg/5 mL. L. Perrigo Company ANDA 74-937 12/22/98 12/22/98 1/10/02 1/10/02 Ibuprofen Suspension USP, 100 mg/5 mL, Alpharma ANDA 74-978 1/30/98 3/25/98 3/19/99 Ibuprofen Suspension USP, 40 mg/mL. L. Perrigo Company ANDA 75-217 12/16/98 12/18/98 12/28/01 12/28/01 Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg & 30 mg, OTC Pharmaceutical Formulations, ANDA 75-588 4/8/02 4/10/03 Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg & 30 mg, OTC Pharmaceutical Formulations, ANDA 75-588 4/17/01 4/24/01 Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg/30 mg, OTC Ohm , ANDA 74-567 4/17/01 4/24/01 Ibuprofen Tablets (round and capsule shaped tablets) USP, 200mg Novopharm N.C. ANDA 74-931 7/20/98 7/20/98 Ibuprofen Tablets (round and capsule shaped tablets) USP, 200mg LNK International ANDA 75-139 3/1/99 3/4/99 Ibuprofen Tablets USP, 200 mg, OTC Dr. Reddy's Ltd. ANDA 76-117 11/20/01 4/16/03 Ibuprofen Tablets USP, 400, 600 & 800 mg, Dr. Reddy's Ltd. ANDA 76-112 10/31/01 1/17/02 1/17/02 Ibuprofen Tablets USP, 200mg, OTC L. Perrigo Company ANDA 75-995 3/14/02 4/10/03 Ibuprofen Tablets USP, 200mg, OTC BASF Corp. ANDA 75-661 12/12/01 Ibuprofen Tablets USP, 200mg LNK International ANDA 75-010 Infant's Motrin (ibuprofen oral suspension) Concentrated Drops, 50 mg/1.25 mL McNeil Consumer Healthcare NDA 20-603/S-003 4/15/99 4/30/02 Infant's Motrin (50 mg/1.25 mL ibuprofen oral suspension). McNeil Consumer & Specialty NDA 20-603/S-005 1/16/02 2/7/02 2/7/02 Infants' Advil (ibuprofen oral suspension) Concentrated Drops,50 mg/1.25 mL. Whitehall-Robins Healthcare NDA 21-812/SE5-003 1/12/00 1/21/00 1/21/00 Infants' Advil Indications: For use in children 6 months - 23 months Motrin Sinus/Headache (Ibuprofen & Pseudoephedrine HCl) Caplets, McNeil Consumer and Specialty NDA 19-899/S15 7/29/03 8/6/03 8/6/03 Motrin Sinus/Headache (Ibuprofen & Pseudoephedrine HCl) Caplets, McNeil Consumer and Specialty NDA 19-899/S8, S11 & S12 9/3/02 9/11/02 Motrin Suspension, Chewable Tablets, Caplets & Drops, McNeil Consumer Healthcare NDA 19482/S-013, 20135/S-005, 20418/S-003 & 20476/S-002 2/4/02 4/17/02 Motrin IB & Children's Motrin (Ibuprofen) Caplets & Suspention, McNeil Consumer NDA 19-012/S34 & 20-516/S11 10/28/03 Motrin Migraine Pain, Tablets Caplets & Geltabs, McNeil Consumer Healthcare NDA 19-012/S016 2/25/00 3/2/00 5/14/02 5/14/02 Motrin Indications: Treats pain of migraine headache. Ibuprofen and Pseudoephedrine Hydrochloride Suspension, Perrigo Co. Motrin IB & Children's Motrin (Ibuprofen) Caplets & Suspention, McNeil Consumer HYDROCODONE BITARTRATE; IBUPROFEN Tablet; 7.5MG;200MG VICOPROFEN Abbott 076023 HYDROCODONE BITARTRATE; IBUPROFEN Tablet; 7.5MG;200MG HYDROCODONE BITARTRATE AND IBUPROFEN Teva 074978 IBUPROFEN Suspension; 100MG/5ML IBUPROFEN ALPHARMA 019842 IBUPROFEN Suspension; 100MG/5ML MOTRIN MCNEIL CONS SPECLT 019833 BX IBUPROFEN Suspension; 100MG/5ML CHILDREN'S ADVIL Wyeth CONS 071058 IBUPROFEN Tablet; 400MG IBU-TAB ALRA | 071059 IBUPROFEN Tablet; 600MG IBU-TAB ALRA | 018197 IBUPROFEN Tablet; 400MG IBU BASF | 070083 IBUPROFEN Tablet; 400MG IBU BASF | 075682 IBUPROFEN Tablet; 400MG IBUPROFEN BASF | 075682 IBUPROFEN Tablet; 600MG IBUPROFEN BASF | 070088 IBUPROFEN Tablet; 600MG IBU BASF | 070099 IBUPROFEN Tablet; 600MG IBU BASF | 070745 IBUPROFEN Tablet; 800MG IBU BASF | 075682 IBUPROFEN Tablet; 800MG IBUPROFEN BASF | 076112 IBUPROFEN Tablet; 400MG IBUPROFEN DR REDDYS INC | 076112 IBUPROFEN Tablet; 600MG IBUPROFEN DR REDDYS INC | 076112 IBUPROFEN Tablet; 800MG IBUPROFEN DR REDDYS INC | 070734 IBUPROFEN Tablet; 300MG IBUPROFEN Geneva 070735 IBUPROFEN Tablet; 400MG IBUPROFEN Geneva 070736 IBUPROFEN Tablet; 600MG IBUPROFEN Geneva 072169 IBUPROFEN Tablet; 800MG IBUPROFEN Geneva 071334 IBUPROFEN Tablet; 400MG IBUPROFEN Interpharm 071335 IBUPROFEN Tablet; 600MG IBUPROFEN Interpharm 071935 IBUPROFEN Tablet; 800MG IBUPROFEN Interpharm 071145 IBUPROFEN Tablet; 400MG IBUPROFEN Ivax 071146 IBUPROFEN Tablet; 600MG IBUPROFEN Ivax 071769 IBUPROFEN Tablet; 800MG IBUPROFEN Ivax 017463 IBUPROFEN Tablet; 300MG MOTRIN MCNEIL CONS SPECLT 017463 IBUPROFEN Tablet; 400MG MOTRIN MCNEIL CONS SPECLT 017463 IBUPROFEN Tablet; 600MG MOTRIN MCNEIL CONS SPECLT 017463 IBUPROFEN Tablet; 800MG MOTRIN MCNEIL CONS SPECLT 071230 IBUPROFEN Tablet; 300MG IBUPROFEN Mutual 071231 IBUPROFEN Tablet; 400MG IBUPROFEN Mutual 071232 IBUPROFEN Tablet; 600MG IBUPROFEN Mutual 072004 IBUPROFEN Tablet; 800MG IBUPROFEN Mutual 070045 IBUPROFEN Tablet; 400MG IBUPROFEN Mylan 070057 IBUPROFEN Tablet; 600MG IBUPROFEN Mylan 071999 IBUPROFEN Tablet; 800MG IBUPROFEN Mylan 070818 IBUPROFEN Tablet; 400MG IBUPROFEN OHM 070469 IBUPROFEN Tablet; 400MG IBUPROHM OHM 070329 IBUPROFEN Tablet; 400MG IBUPROFEN Par 070330 IBUPROFEN Tablet; 600MG IBUPROFEN Par 070986 IBUPROFEN Tablet; 800MG IBUPROFEN Par 071666 IBUPROFEN Tablet; 400MG IBUPROFEN Pliva 071667 IBUPROFEN Tablet; 600MG IBUPROFEN Pliva 071668 IBUPROFEN Tablet; 800MG IBUPROFEN Pliva 071266 IBUPROFEN Tablet; 300MG IBUPROFEN PVT FORM | 071267 IBUPROFEN Tablet; 400MG IBUPROFEN PVT FORM | 071268 IBUPROFEN Tablet; 600MG IBUPROFEN PVT FORM | 072300 IBUPROFEN Tablet; 800MG IBUPROFEN PVT FORM | 071644 IBUPROFEN Tablet; 400MG IBUPROFEN Vintage 070436 IBUPROFEN Tablet; 400MG IBUPROFEN Watson 070437 IBUPROFEN Tablet; 600MG IBUPROFEN Watson 071547 IBUPROFEN Tablet; 800MG IBUPROFEN Watson Ibuprofen Tablets, Neil Children's Motrin (Ibuprofen) Suspension Children's Motrin Cold (Pseudoephedrine HCl) Suspension, McNeil Consumer Hydrocodone Bitartrate and Ibuprofen Tablets USP, Andrx Pharmaceuticals Chilren's ElixSure IB (Ibuprofen) Oral Suspension, Taro Pharmaceuticals Ibuprofen Chewable Tablets, L. Perrigo Co. Ibuprofen Capsules, Banner Pharmacaps, Inc. Children's Advil Allergy Sinus, Wyeth Consumer Healthcare Advil Liqui- Gels & Migraine Liqui-Gels (ibuprofen), Wyeth Consumer Hydrocodone Bitartrate and Ibuprofen Tablets USP, Interpharm Inc., Ibuprofen Tablets USP, LNK International Advil Allergy Sinus Caplets, Wyeth Consumer Healthcare, Labeling Revision Junior Strength Advil (100 mg ibuprofen) tablets, Wyeth, Labeling Revision Infant's Advil (ibuprofen) oral suspension, Wyeth Consumer, Labeling Revision | Ibuprofen Oral Suspension, Perrigo R & D, Approval | Junior Strength & Children’s Advil (100 mg ibuprofen) chewable tablets, Wyeth Consumer, Labeling Revision | Children's Advil Cold/Children's Dimetapp Cold & Fever Suspension, Wyeth Consumer, Labeling Revision | Children’s Motrin (100 mg ibuprofen) oral suspension, McNeil Consumer, Formulation Revision | Children's Advil (Ibuprofen) suspension, Wyeth Consumer, Labeling Revision | Children's Motrin Cold Suspension, McNeil Consumer, Manufacturing Change or Addition

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