Details for New Drug Application (NDA): 202261
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NDA 202261 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-three 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-six 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-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 202261
| Tradename: | MINOCYCLINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202261
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 202261
Suppliers and Packaging for NDA: 202261
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202261 | ANDA | Aurobindo Pharma Limited | 65862-554 | 65862-554-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-554-01) |
| MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202261 | ANDA | Aurobindo Pharma Limited | 65862-554 | 65862-554-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-554-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 45MG BASE | ||||
| Approval Date: | Nov 19, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 65MG BASE | ||||
| Approval Date: | Sep 28, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 90MG BASE | ||||
| Approval Date: | Nov 19, 2012 | TE: | AB | RLD: | No | ||||
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