Details for New Drug Application (NDA): 063009
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NDA 063009 describes MINOCYCLINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin, Pharmobedient, Rising, Sandoz, Sun Pharm, Sun Pharm Inds Ltd, Zydus Pharms, Chartwell Rx, Regcon Holdings, Strides Pharma Intl, Sun Pharm Industries, and Triax Pharms, and is included in twenty-seven NDAs. It is available from twenty-one suppliers. Additional details are available on the MINOCYCLINE HYDROCHLORIDE profile page.
The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 063009
| Tradename: | MINOCYCLINE HYDROCHLORIDE |
| Applicant: | Zydus |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 063009
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 063009
Suppliers and Packaging for NDA: 063009
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 063009 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-317 | 68382-317-01 | 100 CAPSULE in 1 BOTTLE (68382-317-01) |
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 063009 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-318 | 68382-318-18 | 50 CAPSULE in 1 BOTTLE (68382-318-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Mar 2, 1992 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Aug 12, 2003 | TE: | AB | RLD: | No | ||||
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