Product Details for ANDA 204058
LISINOPRIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; LISINOPRIL)
12.5MG;10MG
Marketing Status: Prescription
12.5MG;20MG
Marketing Status: Prescription
25MG;20MG
Marketing Status: Prescription
12.5MG;10MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; LISINOPRIL
Proprietary Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204058
Product Number: 001
Approval Date: May 23, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
LISINOPRIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; LISINOPRIL)
Proprietary Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204058
Product Number: 001
Approval Date: May 23, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
12.5MG;20MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; LISINOPRIL
Proprietary Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;20MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204058
Product Number: 002
Approval Date: May 23, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
LISINOPRIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; LISINOPRIL)
Proprietary Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;20MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204058
Product Number: 002
Approval Date: May 23, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG;20MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; LISINOPRIL
Proprietary Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;20MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204058
Product Number: 003
Approval Date: May 23, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;20MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204058
Product Number: 003
Approval Date: May 23, 2017
Applicant Holder Full Name: INVAGEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information