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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208988

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ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: ZIPRASIDONE HYDROCHLORIDE
Proprietary Name: ZIPRASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208988
Product Number: 001
Approval Date: Aug 22, 2017
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: ZIPRASIDONE HYDROCHLORIDE
Proprietary Name: ZIPRASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208988
Product Number: 002
Approval Date: Aug 22, 2017
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Prescription
Active Ingredient: ZIPRASIDONE HYDROCHLORIDE
Proprietary Name: ZIPRASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208988
Product Number: 003
Approval Date: Aug 22, 2017
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HYDROCHLORIDE)
EQ 80MG BASE
Marketing Status: Prescription
Active Ingredient: ZIPRASIDONE HYDROCHLORIDE
Proprietary Name: ZIPRASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208988
Product Number: 004
Approval Date: Aug 22, 2017
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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