Details for New Drug Application (NDA): 203306
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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 203306
Tradename: | LANSOPRAZOLE |
Applicant: | Natco |
Ingredient: | lansoprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203306
Mechanism of Action | Proton Pump Inhibitors |
Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 203306
Suppliers and Packaging for NDA: 203306
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203306 | ANDA | Rising Pharma Holdings, Inc. | 16571-742 | 16571-742-42 | 3 BOTTLE in 1 CARTON (16571-742-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203306 | ANDA | Bryant Ranch Prepack | 71335-9694 | 71335-9694-1 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9694-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 15MG | ||||
Approval Date: | Jan 13, 2016 | TE: | RLD: | No |
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