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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211248

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PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211248
Product Number: 001
Approval Date: Nov 2, 2021
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211248
Product Number: 002
Approval Date: Nov 2, 2021
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211248
Product Number: 003
Approval Date: Nov 2, 2021
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAROXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211248
Product Number: 004
Approval Date: Nov 2, 2021
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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