Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208687

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AZATHIOPRINE (AZATHIOPRINE)
25MG
Marketing Status: Prescription

Active Ingredient: AZATHIOPRINE
Proprietary Name: AZATHIOPRINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208687
Product Number: 001
Approval Date: Mar 27, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AZATHIOPRINE (AZATHIOPRINE)
50MG
Marketing Status: Prescription

Active Ingredient: AZATHIOPRINE
Proprietary Name: AZATHIOPRINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208687
Product Number: 002
Approval Date: Mar 27, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AZATHIOPRINE (AZATHIOPRINE)
75MG
Marketing Status: Prescription

Active Ingredient: AZATHIOPRINE
Proprietary Name: AZATHIOPRINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208687
Product Number: 003
Approval Date: Mar 27, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AZATHIOPRINE (AZATHIOPRINE)
100MG
Marketing Status: Prescription

Active Ingredient: AZATHIOPRINE
Proprietary Name: AZATHIOPRINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208687
Product Number: 004
Approval Date: Mar 27, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information