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FDA Approval Activities for this Drug…
Atridox (doxycycline hyclate) Atrigel Delivery System, 10 %, Atrix NDA 50-751/S11 6/20/03 7/6/03 7/8/03 | Atridox (doxycycline hyclate) Atrigel Delivery System, Atrix NDA 50-751/S9 3/16/03 | Atridox (doxycycline hyclate, 10.0%) in the Atrigel Delivery System for Controlled Release in Subgingival Application[63.3% N-methyl-2-pyrrolidone and 36.7% poly (DL-lactide)], Atrix NDA 50-751 9/4/98 9/8/98 12/24/98 1/21/99 | Atridox Indication: Provides for the use of Atridox for the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing. Doryx (coated doxycycline hyclate pellets) Capsules, F. H. Faulding & Co, Ltd. NDA 50-582/S-021 6/5/03 | Doryx (coated doxycycline hyclate pellets) Capsules, F. H. Faulding & Co, Ltd. NDA 50-582/S-016 Doxycycline Capsules USP, 50 mg & 100 mg Par ANDA 65-055 12/1/00 2/28/01 | Doxycycline Capsules USP, 75 mg Ranbaxy Ltd. ANDA 65-053/S4 9/10/03 | Doxycycline Capsules USP, 50 mg & 100 mg Ranbaxy Ltd. ANDA 65-053 11/22/00 11/27/00 | Doxycycline Capsules USP, 50 mg & 100 mg Halsey Drug Company, ANDA 65-041 4/28/00 4/28/00 | Doxycycline Capsules USP, 50 mg & 100 mg, Eon Labs Manufacturing ANDA 65-032 6/30/00 10/30/00 | Doxycycline Tablets, 75 mg, Par Pharmaceutical, ANDA 65-070/S5 & S6 12/30/02 | Doxycycline Tablets, 50 mg & 100 mg, Par Pharmaceutical, ANDA 65-070 12/15/00 2/28/01 | Doxycycline Hyclate Tablets, 100 mg, West-Ward Pharmaceutical ANDA 65-095 Monodox (doxycycline monohydrate) Capsules, Watson, NDA 50-641/S-010 6/18/02 6/24/02 | Monodox (doxycycline monohydrate) Capsules, Watson, NDA 50-641/S-008 Periostat Capsules, 20 mg., CollaGenex NDA 50-744 10/1/98 10/1/98 10/1/98 1/13/99 | PerioStat Indication: Provides for the use of Periostat (doxycycline hyclate, USP) Capsules, 20 mg as an adjunct to subgingival scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. | Periostat (doxycycline hyclate) Tablets, 20 mg., CollaGenex NDA 50-783 2/2/01 3/30/01 3/30/01 3/5/02 | PerioStat Indication: Provides for the use of Periostat (doxycycline hyclate, USP) Capsules, 20 mg as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. DOXYCYCLINE Capsule; 100MG BASE DOXYCYCLINE AXIOM 065041 DOXYCYCLINE Capsule; 50MG BASE DOXYCYCLINE AXIOM 065032 DOXYCYCLINE Capsule; 100MG BASE DOXYCYCLINE Eon | 065032 DOXYCYCLINE Capsule; 50MG BASE DOXYCYCLINE Eon | 050641 DOXYCYCLINE Capsule; 100MG BASE MONODOX OCLASSEN | 050641 DOXYCYCLINE Capsule; 50MG BASE MONODOX OCLASSEN | 065055 DOXYCYCLINE Capsule; 100MG BASE DOXYCYCLINE Par | 065055 DOXYCYCLINE Capsule; 50MG BASE DOXYCYCLINE Par | 065053 DOXYCYCLINE Capsule; 100MG BASE DOXYCYCLINE Ranbaxy | 065053 DOXYCYCLINE Capsule; 50MG BASE DOXYCYCLINE Ranbaxy | 050006 DOXYCYCLINE For Suspension; 25MG BASE/5ML VIBRAMYCIN PFIZER | 065070 DOXYCYCLINE Tablet; 100MG BASE DOXYCYCLINE Par | 065070 DOXYCYCLINE Tablet; 50MG BASE DOXYCYCLINE Par | 065070 DOXYCYCLINE Tablet; 75MG BASE DOXYCYCLINE Par | 050480 DOXYCYCLINE CALCIUM Suspension; 50MG BASE/5ML VIBRAMYCIN PFIZER | 050582 DOXYCYCLINE HYCLATE Capsule, Coated Pellets; 100MG BASE DORYX Faulding | 050582 DOXYCYCLINE HYCLATE Capsule, Coated Pellets; 75MG BASE DORYX Faulding | 062653 DOXYCYCLINE HYCLATE Capsule, Coated Pellets; 100MG BASE DORYX WARNER CHILCOTT | 061717 DOXYCYCLINE HYCLATE Capsule; 100MG BASE DOXYCYCLINE HYCLATE AXIOM 061717 DOXYCYCLINE HYCLATE Capsule; 50MG BASE DOXYCYCLINE HYCLATE AXIOM 062500 DOXYCYCLINE HYCLATE Capsule; 100MG BASE DOXYCYCLINE HYCLATE Ivax | 062500 DOXYCYCLINE HYCLATE Capsule; 50MG BASE DOXYCYCLINE HYCLATE Ivax | 062676 DOXYCYCLINE HYCLATE Capsule; 100MG BASE DOXYCYCLINE HYCLATE Mutual | 062675 DOXYCYCLINE HYCLATE Capsule; 50MG BASE DOXYCYCLINE HYCLATE Mutual | 062337 DOXYCYCLINE HYCLATE Capsule; 100MG BASE DOXYCYCLINE HYCLATE Mylan | 062337 DOXYCYCLINE HYCLATE Capsule; 50MG BASE DOXYCYCLINE HYCLATE Mylan | 050007 DOXYCYCLINE HYCLATE Capsule; 100MG BASE VIBRAMYCIN PFIZER | 050007 DOXYCYCLINE HYCLATE Capsule; 50MG BASE VIBRAMYCIN PFIZER | 062031 DOXYCYCLINE HYCLATE Capsule; 100MG BASE DOXYCYCLINE HYCLATE Watson | 062031 DOXYCYCLINE HYCLATE Capsule; 50MG BASE DOXYCYCLINE HYCLATE Watson | 062396 DOXYCYCLINE HYCLATE Capsule; 100MG BASE DOXYCYCLINE HYCLATE West Ward | 062396 DOXYCYCLINE HYCLATE Capsule; 50MG BASE DOXYCYCLINE HYCLATE West Ward | 062475 DOXYCYCLINE HYCLATE Injection 100MG BASE/VIAL DOXY 100 AM PARTNERS | 062475 DOXYCYCLINE HYCLATE Injection 200MG BASE/VIAL DOXY 200 AM PARTNERS | 050751 DOXYCYCLINE HYCLATE Liquid, Extended Release; Periodontal 10% W/W ATRIDOX Atrix | 062269 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE AXIOM 050783 DOXYCYCLINE HYCLATE Tablet; 20MG PERIOSTAT COLLAGENEX 062505 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE Ivax | 062677 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE Mutual | 062432 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE Mylan | 050533 DOXYCYCLINE HYCLATE Tablet; 100MG BASE VIBRA-TABS PFIZER | 062538 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE Vintage | 062421 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE Watson | 065095 DOXYCYCLINE HYCLATE Tablet; 100MG BASE DOXYCYCLINE HYCLATE West Ward Doryx (coated doxycycline hyclate pellets) Capsules, F. H. Faulding & Co, Ltd. Periostat (doxycycline hyclate) Tablets, CollaGenex Pharmaceuticals | Doxycycline Capsules, Par Pharma, Supplement | Doryx (doxycycline hyclate) Delayed-Release Tablets, F. H. Faulding and Co., Approval | Doryx (doxycycline hyclate) Delayed-Release Capsules, F. H. Faulding and Co., Labeling Revision | Doxycycline Hyclate Tablets, Mutual Pharma, Approval | Doxycycline Hyclate Tablets, IVAX Pharma, Approval | Doxycycline Hyclate Tablets, CorePharma, Approval | Doxycycline Hyclate Capsules, West-ward Pharma, Approval | Doxycycline Tablets, Par Pharmaceutical, Supplement | Doxycycline Capsules, Par Pharma, Supplement | Doxycycline Tablets, Lannett Holdings, Approval | Doxycycline Hyclate Delayed Release Capsules, Sandoz Inc., Approval | Doxycycline Hyclate Tablets, Par Pharma, Approval | Oracea (doxycycline, USP) Capsules, CollaGenex Pharma, Approval | Doxycycline Tablets, Ranbaxy Labs, Approval | Doxycycline Tablets, Mylan Pharma, Approval | Doxycycline Tablets, Sandoz Inc., Approval | Doryx (doxycycline hyclate) Delayed-Release Tablets, Warner Chilcott, Efficacy Supp w/Clinical Data | Monodox (doxycycline monohydrate) Capsules, Watson Labs, Control Suppl. | Doxycycline Tablets, Mylan Pharma, Approval | Mondox (doxycycline monohydrate) Capsules, Watson Labs, Labeling Revision | Doryx (doxycycline hyclate) Delayed Release Tablets, Warner Chilcott, Labeling Revision | Doryx (doxycycline hyclate) Delayed-Release Capsules, Warner Chilcott, Labeling Revision | Vibramycin (doxycycline monohydrate) Oral Suspension, Pfizer Inc., Labeling Revision | Vibramycin (doxycycline hyclate) Capsules, Pfizer Inc., Labeling Revision | Vibramycin Calcium (doxycycline hyclate) Syrup, Pfizer Inc., Labeling Revision | Vibramycin (doxycycline hyclate) Film-Coated Tablets, Pfizer Inc., Labeling Revision | Doryx (doxycycline hyclate) Delayed-Release Tablets, Warner Chilcott (U.S.), Inc., Formulation Revision | Doxycycline Oral Suspension, IVAX Pharmaceuticals, Inc., Approval | Doxycycline Tablets, Mutual Pharmaceutical Co., Inc., Approval | Oracea (doxycycline) Capsules, Galderma Laboratories, Labeling Revision | Doxycycline Capsules, Mylan Pharmaceuticals Inc., Approval | Doxycycline Hyclate Delayed-Release Tablets, Impax Laboratories, Inc., Approval | Doxycycline Hyclate Delayed-Release Tablets, Mylan Pharmaceuticals, Inc., Approval | Atridox (doxycycline hyclate) Gel, Tolmar Inc., Labeling Revision | Doxycycline Capsules, Impax Laboratories, Inc., Approval | Monodox (doxycycline monohydrate) Capsules, Watson Pharmaceuticals, Labeling Revision | Doryx (doxycycline hyclate) Delayed-Release Tablets, Mayne Pharmaceuticals International Pty, Ltd., Labeling Revision | Doryx (doxycycline hyclate) Delayed-Release Tablets, Mayne Pharmaceuticals International Pty, Ltd., Labeling Revision | Vibramycin (doxycycline) Oral Suspension, Pfizer Global Research and Development, Labeling Revision | Vibramycin (doxycycline calcium) Oral Suspension, Pfizer Global Research and Development, Labeling Revision | Vibramycin (doxycycline hyclate) Capsules, Pfizer Global Research and Development, Labeling Revision | Vibra-Tabs (doxycycline hyclate) Tablets, Pfizer Global Research and Development, Labeling Revision | Doxycycline Hyclate Delayed-Release Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Doryx (doxycycline hyclate) Delayed-Release Tablets, Mayne Pharmaceuticals, Manufacturing Supplement | Doxycycline Hyclate Delayed-Release Tablets, Actavis Elizabeth LLC, Approval | Doxycycline, doxycycline, Tablet; Oral, Heritage Pharms Inc, Approval
  
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