Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204663

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PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
15MG
Marketing Status: Prescription

Active Ingredient: PHENTERMINE HYDROCHLORIDE
Proprietary Name: PHENTERMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204663
Product Number: 001
Approval Date: Jun 28, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: PHENTERMINE HYDROCHLORIDE
Proprietary Name: PHENTERMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204663
Product Number: 002
Approval Date: Jun 28, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
37.5MG
Marketing Status: Prescription

Active Ingredient: PHENTERMINE HYDROCHLORIDE
Proprietary Name: PHENTERMINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 37.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204663
Product Number: 003
Approval Date: Jun 28, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information