Details for New Drug Application (NDA): 201921
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NDA 201921 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Novitium Pharma, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt Bio Ag, 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-six 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 201921
| Tradename: | LANSOPRAZOLE |
| Applicant: | Natco Pharma Ltd |
| Ingredient: | lansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 201921
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 201921
Suppliers and Packaging for NDA: 201921
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 201921 | ANDA | Rising Pharma Holdings, Inc. | 16571-698 | 16571-698-03 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-03) |
| LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 201921 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3585 | 68071-3585-3 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3585-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 15MG | ||||
| Approval Date: | Dec 18, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 30MG | ||||
| Approval Date: | Dec 18, 2012 | TE: | AB | RLD: | No | ||||
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