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Last Updated: August 10, 2020

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Details for New Drug Application (NDA): 065062

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NDA 065062 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, Mylan Labs Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Dr Reddys Labs Ltd, Par Pharm, Sun Pharm Industries, and Triax Pharms, and is included in twenty-six NDAs. It is available from thirty-two 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-nine suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 065062
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Torrent
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065062
Medical Subject Heading (MeSH) Categories for 065062
Suppliers and Packaging for NDA: 065062
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 065062 ANDA Major Pharamceuticals 0904-6888 0904-6888-06 50 BLISTER PACK in 1 CARTON (0904-6888-06) > 1 CAPSULE in 1 BLISTER PACK
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 065062 ANDA Torrent Pharmaceuticals Limited 13668-482 13668-482-01 100 CAPSULE in 1 BOTTLE (13668-482-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Nov 30, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Nov 30, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Nov 30, 2000TE:ABRLD:No

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