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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217422

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THEOPHYLLINE (THEOPHYLLINE)
300MG
Marketing Status: Prescription
Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217422
Product Number: 001
Approval Date: Sep 8, 2023
Applicant Holder Full Name: ANNORA PHARMA PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
THEOPHYLLINE (THEOPHYLLINE)
450MG
Marketing Status: Prescription
Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 450MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217422
Product Number: 002
Approval Date: Sep 8, 2023
Applicant Holder Full Name: ANNORA PHARMA PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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