Details for New Drug Application (NDA): 207394
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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 207394
Tradename: | LANSOPRAZOLE |
Applicant: | Alkem Labs Ltd |
Ingredient: | lansoprazole |
Patents: | 0 |
Pharmacology for NDA: 207394
Mechanism of Action | Proton Pump Inhibitors |
Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 207394
Suppliers and Packaging for NDA: 207394
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 207394 | ANDA | A-S Medication Solutions | 50090-5180 | 50090-5180-0 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5180-0) |
LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 207394 | ANDA | A-S Medication Solutions | 50090-5180 | 50090-5180-1 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5180-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 15MG | ||||
Approval Date: | Jan 18, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 18, 2019 | TE: | AB | RLD: | No |
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