Product Details for NDA 021507
PREVACID NAPRAPAC 250 (COPACKAGED) (LANSOPRAZOLE; NAPROXEN)
15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG,N/A;N/A,375MG
Marketing Status: Discontinued
15MG,N/A;N/A,500MG
Marketing Status: Discontinued
15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LANSOPRAZOLE; NAPROXEN
Proprietary Name: PREVACID NAPRAPAC 250 (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
Strength: 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021507
Product Number: 002
Approval Date: Nov 14, 2003
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREVACID NAPRAPAC 375 (COPACKAGED) (LANSOPRAZOLE; NAPROXEN)
Proprietary Name: PREVACID NAPRAPAC 250 (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
Strength: 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021507
Product Number: 002
Approval Date: Nov 14, 2003
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG,N/A;N/A,375MG
Marketing Status: Discontinued
Active Ingredient: LANSOPRAZOLE; NAPROXEN
Proprietary Name: PREVACID NAPRAPAC 375 (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
Strength: 15MG,N/A;N/A,375MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021507
Product Number: 003
Approval Date: Nov 14, 2003
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
PREVACID NAPRAPAC 500 (COPACKAGED) (LANSOPRAZOLE; NAPROXEN)
Proprietary Name: PREVACID NAPRAPAC 375 (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
Strength: 15MG,N/A;N/A,375MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021507
Product Number: 003
Approval Date: Nov 14, 2003
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG,N/A;N/A,500MG
Marketing Status: Discontinued
Active Ingredient: LANSOPRAZOLE; NAPROXEN
Proprietary Name: PREVACID NAPRAPAC 500 (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
Strength: 15MG,N/A;N/A,500MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021507
Product Number: 004
Approval Date: Nov 14, 2003
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PREVACID NAPRAPAC 500 (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS, TABLET; ORAL
Strength: 15MG,N/A;N/A,500MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021507
Product Number: 004
Approval Date: Nov 14, 2003
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Marketing Status: Discontinued
Patent and Exclusivity Information