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MINOCYCLINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Arestin (Minocycline Hydrochloride) Microspheres, 1 mg, OraPharma, NDA 50-781 Minocin (minocycline hydrochloride) Pellet-Filled Capsules, Wyeth-Ayerst Research NDA 50-649/S5 & S7 2/1/02 4/17/02 Minocin (minocycline hydrochloride) Intravenous, Suspension & Pellet-Filled Capsules, Wyeth NDA 50-444/S36, 50-445/S19 & 50649S11 5/31/02 6/3/02 Minocin (minocycline hydrochloride) Suspension, Wyeth-Ayerst Research NDA 50-445/S-11, S-13, S-15 & S-17 2/1/02 4/17/02 Minocin (minocycline hydrochloride) Intravenous, Wyeth-Ayerst Research NDA 50-444/S-029, S-033 & S-034 1/30/02 3/6/02 Minocycline Hydrochloride Capsules USP, 50 mg (base), 75 mg (base) and 100 mg (base), Ranbaxy Limited ANDA 65-062 11/30/00 2/28/01 Minocycline Hydrochloride Capsules, 75 mg (base) Teva ANDA 65-009/S24 & S25 8/13/03 Minocycline Hydrochloride Capsules USP, 50 mg (base) and 100 mg (base) Global Pharmaceutical Corp. ANDA 65-005 3/23/99 3/29/99 1/15/02 Minocycline Hydrochloride Capsules USP, 100 mg (base), Danbury Pharmacal, ANDA 63-065/S14, S15 6/10/99 8/6/02 7/24/03 Minocycline Hydrochloride Tablets USP, 50, 75 & 100 mg (base), Par Pharmaceutical ANDA 65-131 MINOCYCLINE HYDROCHLORIDE Capsule; 100MG BASE MINOCYCLINE HCL Impax | 065005 MINOCYCLINE HYDROCHLORIDE Capsule; 50MG BASE MINOCYCLINE HCL Impax | 065005 MINOCYCLINE HYDROCHLORIDE Capsule; 75MG BASE MINOCYCLINE HCL Impax | 063066 MINOCYCLINE HYDROCHLORIDE Capsule; 50MG BASE VECTRIN MEDICIS | 065062 MINOCYCLINE HYDROCHLORIDE Capsule; 100MG BASE MINOCYCLINE HCL Ranbaxy | 065062 MINOCYCLINE HYDROCHLORIDE Capsule; 50MG BASE MINOCYCLINE HCL Ranbaxy | 065062 MINOCYCLINE HYDROCHLORIDE Capsule; 75MG BASE MINOCYCLINE HCL Ranbaxy | 063009 MINOCYCLINE HYDROCHLORIDE Capsule; 100MG BASE MINOCYCLINE HCL Teva | 063011 MINOCYCLINE HYDROCHLORIDE Capsule; 50MG BASE MINOCYCLINE HCL Teva | 063009 MINOCYCLINE HYDROCHLORIDE Capsule; 75MG BASE MINOCYCLINE HCL Teva | 063065 MINOCYCLINE HYDROCHLORIDE Capsule; 100MG BASE MINOCYCLINE HCL Watson | 063181 MINOCYCLINE HYDROCHLORIDE Capsule; 50MG BASE MINOCYCLINE HCL Watson | 063065 MINOCYCLINE HYDROCHLORIDE Capsule; 75MG BASE MINOCYCLINE HCL Watson | 050649 MINOCYCLINE HYDROCHLORIDE Capsule; 100MG BASE MINOCIN Wyeth INC | 050649 MINOCYCLINE HYDROCHLORIDE Capsule; 50MG BASE MINOCIN Wyeth INC | 050649 MINOCYCLINE HYDROCHLORIDE Capsule; 75MG BASE MINOCIN Wyeth INC | 050444 MINOCYCLINE HYDROCHLORIDE Injection 100MG BASE/VIAL MINOCIN Wyeth INC | 050781 MINOCYCLINE HYDROCHLORIDE Powder, Extended Release; Dental 1MG BASE ARESTIN ORAPHARMA | 065131 MINOCYCLINE HYDROCHLORIDE Tablet; 100MG BASE MINOCYCLINE HCL MEDICIS | 065131 MINOCYCLINE HYDROCHLORIDE Tablet; 50MG BASE MINOCYCLINE HCL MEDICIS | 065131 MINOCYCLINE HYDROCHLORIDE Tablet; 75MG BASE MINOCYCLINE HCL MEDICIS | Medicis Pharmaceutical Corp Solodyn (minocycline) | Minocycline Hydrochloride Tablets USP, Ranbaxy Laboratories MINOCIN (minocycline for injection), Intravenous, Wyeth Pharmaceuticals MINOCIN (minocycline hydrochloride), Pellet-filled Capsules, Wyeth Pharmaceuticals | Minocin (Minocycline) Injection, Wyeth Pharma, Supplement | 050444 | Minocin (Minocycline Hydrochloride) Oral Suspension, Wyeth Pharma, Supplement | Minocin (Minocycline Hydrochloride) Pellet-filled Capsules, Wyeth Pharma, Supplement | Minocin (sterile minocycline hydrochloride) Intravenous, Triax Pharma, Labeling Revision | Minocin (minocycline hydrochloride) Oral Suspension, Triax Pharma, Labeling Revision | Minocin (sterile minocycline hydrochloride) Pellet Filled Capsules, Triax Pharma, Labeling Revision | Minocin (minocycline) Pellet-Filled Capsules, Triax Pharma, Labeling Revision | Minocin (minocycline hydrochloride) Pellet-Filled Capsules, Triax Pharma, Manufacturing Change or Addition | Minocycline Hydrochloride Tablets, Indicus Pharma, Approval | ARESTIN (minocycline hydrochloride) Microspheres, OraPharma Inc., Labeling Revision | Minocycline Hydrochloride Capsules, Aurobindo Pharma, Approval | Minocin (minocycline hydrochloride) Capsules, Triax Pharmaceuticals, LLC, Labeling Revision | Minocycline Hydrochloride Extended-release Tablets, Impax Laboratories, Inc., Approval | Minocycline Hydrochloride Extended-Release Tablets, Barr Laboratories, Inc., Approval | Solodyn (minocycline HCl) Extended Release Tablets, Medicis Pharmaceutical Corporation, Control Supplement | Minocycline Hydrochloride Tablets, Sandoz Inc., Approval | Solodyn (minocycline hydrochloride) Extended Release Tablets, Medicis Pharmaceutical Corp., Labeling Revision | Solodyn (minocycline hydrochloride) Extended-Release Tablets, Medicis Pharmaceutical Corporation, Labeling Revision | Minocin (minocycline hydrochloride) Injection, Triax Pharmaceuticals, Inc., Labeling Revision | Minocin (minocycline hydrochloride) Capsules, Triax Pharmaceuticals, Inc., Labeling Revision | Minocin (minocycline hydrochloride) Oral Suspension, Triax Pharmaceuticals, Inc., Labeling Revision | Solodyn (minocycline hydrochloride) Extended-Release Tablets, Medicis Pharmaceutical Corp., Labeling Revision | Solodyn (minocycline hydrochloride) Extended-Release Tablets, Medicis Pharmaceutical Corp., Labeling Revision | Minocycline Hydrochloride Extended-Release Tablets, Lupin Pharmaceuticals, Inc., Approval | Minocycline Hydrochloride, minocycline hydrochloride, Tablet, Extended Release; Oral, Mylan Labs, Tentative Approval | Ximino, minocycline hydrochloride, Capsule, Extended Release; Oral, Ranbaxy Labs Ltd, Approval | Arestin, minocycline hydrochloride, Powder, Extended Release; Dental, Orapharma, Labeling Revision | Minocycline Hydrochloride, minocycline hydrochloride, Tablet, Extended Release; Oral, Aurobindo Pharma Ltd, Approval | Minocycline Hydrochloride, minocycline hydrochloride, Tablet, Extended Release; Oral, Aurobindo Pharma Ltd, Tentative Approval | Solodyn, minocycline hydrochloride, Tablet, Extended Release; Oral, Medicis, Manufacturing Change or Addition | Minocycline Hydrochloride, minocycline hydrochloride, Capsule; Oral, Caraco, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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