Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212451

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MORPHINE SULFATE (MORPHINE SULFATE)
15MG
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212451
Product Number: 001
Approval Date: Dec 3, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MORPHINE SULFATE (MORPHINE SULFATE)
30MG
Marketing Status: Prescription

Active Ingredient: MORPHINE SULFATE
Proprietary Name: MORPHINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212451
Product Number: 002
Approval Date: Dec 3, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information