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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204453


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NDA 204453 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 204453
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Alkem Labs Ltd
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204453
Physiological EffectDecreased Prothrombin Activity
Medical Subject Heading (MeSH) Categories for 204453
Suppliers and Packaging for NDA: 204453
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 204453 ANDA Bryant Ranch Prepack 63629-9208 63629-9208-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9208-1)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 204453 ANDA Bryant Ranch Prepack 63629-9209 63629-9209-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9209-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Sep 28, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 80MG BASE
Approval Date:Sep 28, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 90MG BASE
Approval Date:Sep 28, 2016TE:ABRLD:No

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