Details for New Drug Application (NDA): 090217
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NDA 090217 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, Norvium Bioscience, Rising, Sandoz, Sun Pharm, Sun Pharm Inds Ltd, Zydus Pharms, Beximco Pharms Usa, Dr Reddys Labs Ltd, Strides Pharma, Sun Pharm Industries, and Triax Pharms, and is included in twenty-seven NDAs. It is available from twenty-nine 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. Thirty-two 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. Thirty-two suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 090217
| Tradename: | MINOCYCLINE HYDROCHLORIDE |
| Applicant: | Sun Pharm Industries |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090217
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 090217 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-854 | 57664-854-13 | 500 TABLET, FILM COATED in 1 BOTTLE (57664-854-13) |
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET;ORAL | 090217 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-854 | 57664-854-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (57664-854-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jan 29, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jan 29, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jan 29, 2016 | TE: | RLD: | No | |||||
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