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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 219477

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PREDNISONE (PREDNISONE)
1MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A219477
Product Number: 001
Approval Date: Oct 1, 2025
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PREDNISONE (PREDNISONE)
2MG
Marketing Status: Prescription
Active Ingredient: PREDNISONE
Proprietary Name: PREDNISONE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A219477
Product Number: 002
Approval Date: Oct 1, 2025
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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