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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040500

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PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
12.5MG
Marketing Status: Prescription
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040500
Product Number: 001
Approval Date: Jun 30, 2003
Applicant Holder Full Name: PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
25MG
Marketing Status: Prescription
Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040500
Product Number: 002
Approval Date: Jun 30, 2003
Applicant Holder Full Name: PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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