Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020406

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PREVACID (LANSOPRAZOLE)
30MG
Marketing Status: Prescription

Active Ingredient: LANSOPRAZOLE
Proprietary Name: PREVACID
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020406
Product Number: 002
Approval Date: May 10, 1995
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PREVACID (LANSOPRAZOLE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: LANSOPRAZOLE
Proprietary Name: PREVACID
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020406
Product Number: 001
Approval Date: May 10, 1995
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information