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Generated: April 30, 2017

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Details for New Drug Application (NDA): 065131

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NDA 065131 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, 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. Forty-nine suppliers are listed for this compound. There are fifteen tentative approvals for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for NDA: 065131

Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 065131


Suppliers and Packaging for NDA: 065131

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
minocycline hydrochloride
TABLET;ORAL 065131 ANDA AvKARE, Inc. 42291-589 42291-589-90 90 TABLET in 1 BOTTLE (42291-589-90)
minocycline hydrochloride
TABLET;ORAL 065131 ANDA AvKARE, Inc. 42291-591 42291-591-60 60 TABLET in 1 BOTTLE (42291-591-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Apr 16, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Apr 16, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 16, 2003TE:ABRLD:No

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