Details for New Drug Application (NDA): 210465
NDA 210465 describes LANSOPRAZOLE, which is a drug marketed by Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms, Hetero Labs Ltd Iii, Krka Tovarna Zdravil, Lannett Co Inc, Macleods Pharms, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Novitium Pharma, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Xiromed, Zydus Hlthcare, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising, and is included in thirty-four NDAs. It is available from sixty 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 two 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 two 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 210465
| Tradename: | LANSOPRAZOLE |
| Applicant: | Dr Reddys |
| Ingredient: | lansoprazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210465
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Feb 1, 2021 | 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: | Feb 1, 2021 | TE: | AB | RLD: | No | ||||
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