Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209177

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PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
12.5MG
Marketing Status: Discontinued

Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209177
Product Number: 001
Approval Date: Jun 30, 2017
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
25MG
Marketing Status: Discontinued

Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209177
Product Number: 002
Approval Date: Jun 30, 2017
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
50MG
Marketing Status: Discontinued

Active Ingredient: PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209177
Product Number: 003
Approval Date: Jun 30, 2017
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information