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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020215

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MONOKET (ISOSORBIDE MONONITRATE)
10MG
Marketing Status: Prescription
Active Ingredient: ISOSORBIDE MONONITRATE
Proprietary Name: MONOKET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020215
Product Number: 002
Approval Date: Jun 30, 1993
Applicant Holder Full Name: OMNIVIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
MONOKET (ISOSORBIDE MONONITRATE)
20MG
Marketing Status: Prescription
Active Ingredient: ISOSORBIDE MONONITRATE
Proprietary Name: MONOKET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020215
Product Number: 001
Approval Date: Jun 30, 1993
Applicant Holder Full Name: OMNIVIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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