Details for New Drug Application (NDA): 065131
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NDA 065131 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, Chartwell Rx, Impax Labs Inc, Pharmobedient, Rising, Sandoz, Sun Pharm, Sun Pharm Inds Ltd, Zydus Pharms, 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 065131
| Tradename: | MINOCYCLINE HYDROCHLORIDE |
| Applicant: | Strides Pharma Intl |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065131
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 065131 | ANDA | Strides Pharma Science Limited | 64380-154 | 64380-154-01 | 100 TABLET in 1 BOTTLE (64380-154-01) |
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 065131 | ANDA | Strides Pharma Science Limited | 64380-155 | 64380-155-01 | 100 TABLET in 1 BOTTLE (64380-155-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Apr 16, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Apr 16, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 16, 2003 | TE: | AB | RLD: | No | ||||
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