Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 083312

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PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
25MG/ML
Marketing Status: Prescription

Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: A083312
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
50MG/ML
Marketing Status: Prescription

Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: A083312
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information