Details for New Drug Application (NDA): 200816
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NDA 200816 describes LANSOPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Chartwell Molecular, Dr Reddys Labs Ltd, Esjay Pharma, 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 sixty-seven 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 200816
| Tradename: | LANSOPRAZOLE |
| Applicant: | Zydus Pharms |
| Ingredient: | lansoprazole |
| Patents: | 0 |
Pharmacology for NDA: 200816
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 200816
Suppliers and Packaging for NDA: 200816
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 200816 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-771 | 68382-771-77 | 10 BLISTER PACK in 1 CARTON (68382-771-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-771-30) |
| LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 200816 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-772 | 68382-772-77 | 10 BLISTER PACK in 1 CARTON (68382-772-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-772-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Nov 27, 2018 | 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: | Nov 27, 2018 | TE: | AB | RLD: | No | ||||
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