Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206993

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FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A206993
Product Number: 001
Approval Date: May 23, 2019
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A206993
Product Number: 002
Approval Date: May 23, 2019
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: FLUOXETINE HYDROCHLORIDE
Proprietary Name: FLUOXETINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206993
Product Number: 003
Approval Date: May 23, 2019
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information