Product Details for ANDA 091352
OMEPRAZOLE (OMEPRAZOLE)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091352
Product Number: 001
Approval Date: Nov 19, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
OMEPRAZOLE (OMEPRAZOLE)
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091352
Product Number: 001
Approval Date: Nov 19, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091352
Product Number: 002
Approval Date: Nov 19, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
OMEPRAZOLE (OMEPRAZOLE)
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091352
Product Number: 002
Approval Date: Nov 19, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091352
Product Number: 003
Approval Date: Nov 19, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091352
Product Number: 003
Approval Date: Nov 19, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information