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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 065005


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NDA 065005 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, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Rising, Sandoz, Sidmak Labs India, 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 thirty 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-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 065005
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Impax Labs
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065005

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Mar 23, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Mar 23, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Apr 18, 2001TE:ABRLD:No

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