Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215420

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SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)
100MG/PACKET
Marketing Status: Prescription

Active Ingredient: SAPROPTERIN DIHYDROCHLORIDE
Proprietary Name: SAPROPTERIN DIHYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; ORAL
Strength: 100MG/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215420
Product Number: 001
Approval Date: Aug 18, 2022
Applicant Holder Full Name: ANNORA PHARMA PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE)
500MG/PACKET
Marketing Status: Prescription

Active Ingredient: SAPROPTERIN DIHYDROCHLORIDE
Proprietary Name: SAPROPTERIN DIHYDROCHLORIDE
Dosage Form; Route of Administration: POWDER; ORAL
Strength: 500MG/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215420
Product Number: 002
Approval Date: Aug 18, 2022
Applicant Holder Full Name: ANNORA PHARMA PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information