Details for New Drug Application (NDA): 208025
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NDA 208025 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Breckenridge, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt, Xiromed, Zydus Hlthcare, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising, and is included in thirty-three NDAs. It is available from seventy suppliers. There are two patents protecting this drug. Additional details are available on the LANSOPRAZOLE profile page.
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.
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 208025
| Tradename: | LANSOPRAZOLE |
| Applicant: | Dexcel |
| Ingredient: | lansoprazole |
| Patents: | 2 |
Pharmacology for NDA: 208025
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 208025
Suppliers and Packaging for NDA: 208025
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208025 | NDA | L. Perrigo Company | 0113-0116 | 0113-0116-55 | 3 CARTON in 1 CARTON (0113-0116-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208025 | NDA | Walgreen Company | 0363-1419 | 0363-1419-55 | 3 CARTON in 1 CARTON (0363-1419-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Jun 7, 2016 | TE: | RLD: | No | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 21, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 21, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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