Product Details for ANDA 204375
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
EQ 40MG BASE
Marketing Status: Prescription
EQ 60MG BASE
Marketing Status: Prescription
EQ 80MG BASE
Marketing Status: Prescription
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: A204375
Product Number: 001
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ZIPRASIDONE HYDROCHLORIDE (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: A204375
Product Number: 001
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A204375
Product Number: 002
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ZIPRASIDONE HYDROCHLORIDE (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: A204375
Product Number: 002
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A204375
Product Number: 003
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ZIPRASIDONE HYDROCHLORIDE (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: A204375
Product Number: 003
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A204375
Product Number: 004
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A204375
Product Number: 004
Approval Date: Feb 17, 2017
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information