Details for New Drug Application (NDA): 203083
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NDA 203083 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, Macleods Pharms Ltd, 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-four 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 203083
| Tradename: | LANSOPRAZOLE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | lansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 203083
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 203083
Suppliers and Packaging for NDA: 203083
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203083 | ANDA | Camber Pharmaceuticals, Inc. | 31722-570 | 31722-570-01 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-01) |
| LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203083 | ANDA | Camber Pharmaceuticals, Inc. | 31722-570 | 31722-570-05 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 15MG | ||||
| Approval Date: | May 18, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 30MG | ||||
| Approval Date: | May 18, 2020 | TE: | AB | RLD: | No | ||||
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