Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210918

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ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE)
30MG
Marketing Status: Prescription

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: AB
Application Number: A210918
Product Number: 001
Approval Date: Nov 5, 2018
Applicant Holder Full Name: RICONPHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE)
60MG
Marketing Status: Prescription

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: AB
Application Number: A210918
Product Number: 002
Approval Date: Nov 5, 2018
Applicant Holder Full Name: RICONPHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE)
120MG
Marketing Status: Prescription

Active Ingredient: ISOSORBIDE MONONITRATE
Proprietary Name: ISOSORBIDE MONONITRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A210918
Product Number: 003
Approval Date: Nov 5, 2018
Applicant Holder Full Name: RICONPHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information