Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202261

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NDA 202261 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-five NDAs. It is available from forty 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. Forty-nine suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 202261
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202261
Medical Subject Heading (MeSH) Categories for 202261
Suppliers and Packaging for NDA: 202261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 202261 ANDA NorthStar Rx LLC 16714-102 16714-102-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-102-01)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 202261 ANDA NorthStar Rx LLC 16714-103 16714-103-01 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-103-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Nov 19, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 65MG BASE
Approval Date:Sep 28, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 90MG BASE
Approval Date:Nov 19, 2012TE:ABRLD:No

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