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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 065470


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NDA 065470 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, Norvium Bioscience, Rising, Sandoz, Sun Pharm, 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 twenty-nine 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-two suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 065470
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Aurobindo Pharma
Ingredient:minocycline hydrochloride
Patents:0
Pharmacology for NDA: 065470
Physiological EffectDecreased Prothrombin Activity
Medical Subject Heading (MeSH) Categories for 065470
Suppliers and Packaging for NDA: 065470
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 065470 ANDA A-S Medication Solutions 50090-2579 50090-2579-0 60 CAPSULE in 1 BOTTLE (50090-2579-0)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 065470 ANDA A-S Medication Solutions 50090-2579 50090-2579-2 20 CAPSULE in 1 BOTTLE (50090-2579-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Mar 11, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Mar 11, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Mar 11, 2008TE:ABRLD:No

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