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Details for New Drug Application (NDA): 091424

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NDA 091424 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 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-six 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: 091424

Tradename:
MINOCYCLINE HYDROCHLORIDE
Applicant:
Lupin Ltd
Ingredient:
minocycline hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091424

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 091424

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL 091424 ANDA Lupin Pharmaceuticals, Inc. 68180-379 68180-379-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-379-01)
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL 091424 ANDA Lupin Pharmaceuticals, Inc. 68180-379 68180-379-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-379-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Nov 30, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 55MG BASE
Approval Date:Nov 30, 2011TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 90MG BASE
Approval Date:Nov 30, 2011TE:ABRLD:No


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