Details for New Drug Application (NDA): 050444
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NDA 050444 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 two 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-five 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-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 050444
| Tradename: | MINOCIN |
| Applicant: | Rempex |
| Ingredient: | minocycline hydrochloride |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050444
| Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 050444
Suppliers and Packaging for NDA: 050444
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOCIN | minocycline hydrochloride | INJECTABLE;INJECTION | 050444 | NDA | Melinta Therapeutics, LLC | 70842-160 | 70842-160-10 | 10 VIAL in 1 CARTON (70842-160-10) / 1 INJECTION in 1 VIAL (70842-160-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 12, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 12, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
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