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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076813

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ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE)
30MG
Marketing Status: Discontinued
Active Ingredient: ISOSORBIDE MONONITRATE
Proprietary Name: ISOSORBIDE MONONITRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076813
Product Number: 002
Approval Date: Mar 30, 2006
Applicant Holder Full Name: HIKMA INTERNATIONAL PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE)
60MG
Marketing Status: Discontinued
Active Ingredient: ISOSORBIDE MONONITRATE
Proprietary Name: ISOSORBIDE MONONITRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076813
Product Number: 001
Approval Date: Jan 7, 2005
Applicant Holder Full Name: HIKMA INTERNATIONAL PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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