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Generated: November 17, 2017

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 Impax Labs, Zydus Worldwide, Mylan Pharms Inc, Sun Pharm Inds, Sun Pharm Inds Ltd, Sandoz, Impax Labs Inc, Lupin Ltd, Par Pharm, Dr Reddys Labs Ltd, Triax Pharms, Alkem Labs Ltd, Torrent Pharma Inc, Aurobindo Pharma Ltd, Watson Labs, Sun Pharm Inds Inc, Aurobindo Pharma, Watson Labs Teva, Barr Labs Inc, and Sidmak Labs India, and is included in twenty-three NDAs. It is available from forty-three suppliers. Additional details are available on the MINOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for 202261

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202261

Ingredient-typeTetracyclines

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 PruGen Pharmaceuticals 42546-771 42546-771-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42546-771-30)
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202261 ANDA PruGen Pharmaceuticals 42546-774 42546-774-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42546-774-30)

Summary for product number 001

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

Summary for product number 003

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

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 135MG BASE
Approval Date:Nov 19, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
Argus Health
Baxter
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