Details for New Drug Application (NDA): 201921
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The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 201921
Tradename: | LANSOPRAZOLE |
Applicant: | Natco Pharma Ltd |
Ingredient: | lansoprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201921
Mechanism of Action | Proton Pump Inhibitors |
Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 201921
Suppliers and Packaging for NDA: 201921
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 201921 | ANDA | Rising Pharma Holdings, Inc. | 16571-697 | 16571-697-03 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-03) |
LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 201921 | ANDA | Rising Pharma Holdings, Inc. | 16571-697 | 16571-697-50 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 15MG | ||||
Approval Date: | Dec 18, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 30MG | ||||
Approval Date: | Dec 18, 2012 | TE: | AB | RLD: | No |
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