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Generated: April 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063067

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NDA 063067 describes DYNACIN, which is a drug marketed by Cnty Line Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the DYNACIN profile page.

The generic ingredient in DYNACIN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 063067
Applicant:Cnty Line Pharms
Ingredient:minocycline hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 063067
Medical Subject Heading (MeSH) Categories for 063067
Suppliers and Packaging for NDA: 063067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYNACIN minocycline hydrochloride CAPSULE;ORAL 063067 ANDA Alvogen, Inc. 47781-545 47781-545-01 100 CAPSULE in 1 BOTTLE (47781-545-01)
DYNACIN minocycline hydrochloride CAPSULE;ORAL 063067 ANDA Alvogen, Inc. 47781-546 47781-546-05 500 CAPSULE in 1 BOTTLE (47781-546-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Jul 31, 1990TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Sep 15, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 14, 1990TE:ABRLD:No

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