Details for New Drug Application (NDA): 207167
✉ Email this page to a colleague
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 207167
Tradename: | LANSOPRAZOLE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | lansoprazole |
Patents: | 0 |
Pharmacology for NDA: 207167
Mechanism of Action | Proton Pump Inhibitors |
Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 207167
Suppliers and Packaging for NDA: 207167
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 207167 | ANDA | Aurobindo Pharma Limited | 65862-895 | 65862-895-78 | 10 BLISTER PACK in 1 CARTON (65862-895-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (65862-895-10) |
LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 207167 | ANDA | Aurobindo Pharma Limited | 65862-896 | 65862-896-78 | 10 BLISTER PACK in 1 CARTON (65862-896-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (65862-896-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Mar 28, 2023 | 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: | Mar 28, 2023 | TE: | AB | RLD: | No |
Complete Access Available with Subscription