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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065470

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NDA 065470 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-two 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. Additional details are available on the minocycline hydrochloride profile page.

Summary for NDA: 065470

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

Pharmacology for NDA: 065470

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 065470

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
CAPSULE;ORAL 065470 ANDA Unit Dose Services 50436-0107 50436-0107-1 30 CAPSULE in 1 BOTTLE (50436-0107-1)
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
CAPSULE;ORAL 065470 ANDA Unit Dose Services 50436-0107 50436-0107-2 60 CAPSULE in 1 BOTTLE (50436-0107-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Mar 11, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Mar 11, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Mar 11, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Dow
AstraZeneca
Teva
Chinese Patent Office
UBS
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Chubb
Medtronic
Baxter

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