Details for New Drug Application (NDA): 201467
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NDA 201467 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 201467
| Tradename: | MINOCYCLINE HYDROCHLORIDE |
| Applicant: | Rising |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 201467
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 65MG BASE | ||||
| Approval Date: | Jul 30, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 115MG BASE | ||||
| Approval Date: | Jul 30, 2019 | TE: | RLD: | No | |||||
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