Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212645

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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: A212645
Product Number: 001
Approval Date: Aug 27, 2021
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
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: A212645
Product Number: 002
Approval Date: Aug 27, 2021
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 37.5MG BASE
Marketing Status: Prescription

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 37.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212645
Product Number: 003
Approval Date: Aug 27, 2021
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information