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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050451


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NDA 050451 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.
Summary for 050451
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Triax Pharms
Ingredient:minocycline hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 050451
Anti-Bacterial Agents

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 10, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 10, 1982TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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