Details for New Drug Application (NDA): 208784
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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 208784
Tradename: | LANSOPRAZOLE |
Applicant: | Teva Pharms Usa |
Ingredient: | lansoprazole |
Patents: | 0 |
Pharmacology for NDA: 208784
Mechanism of Action | Proton Pump Inhibitors |
Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 208784
Suppliers and Packaging for NDA: 208784
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208784 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3008 | 0093-3008-93 | 100 BLISTER PACK in 1 CARTON (0093-3008-93) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0093-3008-19) |
LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208784 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3009 | 0093-3009-93 | 100 BLISTER PACK in 1 CARTON (0093-3009-93) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0093-3009-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Sep 21, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
Approval Date: | Sep 21, 2017 | TE: | AB | RLD: | No |
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