Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075155

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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: A075155
Product Number: 002
Approval Date: Jan 13, 2000
Applicant Holder Full Name: CHARTWELL MOLECULAR HOLDINGS 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: A075155
Product Number: 001
Approval Date: Oct 30, 1998
Applicant Holder Full Name: CHARTWELL MOLECULAR HOLDINGS 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: No
TE Code: AB
Application Number: A075155
Product Number: 003
Approval Date: Aug 4, 2000
Applicant Holder Full Name: CHARTWELL MOLECULAR HOLDINGS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information