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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "050808."



Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: SOLODYN
Applicant: MEDICIS
Strength: EQ 65MG BASE
Application Number: N050808
Product Number: 004
Approval Date: Jul 23, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: SOLODYN
Applicant: MEDICIS
Strength: EQ 115MG BASE
Application Number: N050808
Product Number: 005
Approval Date: Jul 23, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: SOLODYN
Applicant: MEDICIS
Strength: EQ 105MG BASE
Application Number: N050808
Product Number: 006
Approval Date: Aug 27, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: SOLODYN
Applicant: MEDICIS
Strength: EQ 80MG BASE
Application Number: N050808
Product Number: 007
Approval Date: Aug 27, 2010
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: SOLODYN
Applicant: MEDICIS
Strength: EQ 55MG BASE
Application Number: N050808
Product Number: 008
Approval Date: Aug 27, 2010
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 2014
Patent and Generic Drug Product Data Last Updated July 29, 2014

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