Product Details for ANDA 212198
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
5MG;500MG
Marketing Status: Discontinued
5MG;1GM
Marketing Status: Discontinued
12.5MG;500MG
Marketing Status: Discontinued
12.5MG;1GM
Marketing Status: Discontinued
5MG;500MG
Marketing Status: Discontinued
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 001
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 001
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG;1GM
Marketing Status: Discontinued
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;1GM
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 002
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;1GM
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 002
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
12.5MG;500MG
Marketing Status: Discontinued
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 003
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 003
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
12.5MG;1GM
Marketing Status: Discontinued
Active Ingredient: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;1GM
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 004
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;1GM
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212198
Product Number: 004
Approval Date: Jul 7, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information