Details for New Drug Application (NDA): 203553
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NDA 203553 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 203553
| Tradename: | MINOCYCLINE HYDROCHLORIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203553
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 203553
Suppliers and Packaging for NDA: 203553
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203553 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-531 | 68382-531-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-01) |
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203553 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-531 | 68382-531-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-531-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 45MG BASE | ||||
| Approval Date: | Nov 16, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 55MG BASE | ||||
| Approval Date: | Jun 16, 2023 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 65MG BASE | ||||
| Approval Date: | Jun 16, 2023 | TE: | RLD: | No | |||||
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