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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077873

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PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 12.5MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077873
Product Number: 001
Approval Date: Jun 29, 2007
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077873
Product Number: 002
Approval Date: Jun 29, 2007
Applicant Holder Full Name: AUROBINDO PHARMA USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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