Details for New Drug Application (NDA): 050649
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NDA 050649 describes MINOCIN, which is a drug marketed by Bausch, Triax Pharms, Lederle, and Rempex, and is included in five NDAs. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the MINOCIN profile page.
The generic ingredient in MINOCIN 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 MINOCIN 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 050649
| Tradename: | MINOCIN |
| Applicant: | Bausch |
| Ingredient: | minocycline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050649
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCIN | minocycline hydrochloride | CAPSULE;ORAL | 050649 | NDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-172 | 43353-172-83 | 3600 CAPSULE, COATED PELLETS in 1 BOTTLE (43353-172-83) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | May 31, 1990 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | May 31, 1990 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 12, 2001 | TE: | RLD: | Yes | |||||
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