Details for New Drug Application (NDA): 205761
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NDA 205761 describes RABEPRAZOLE SODIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Norvium Bioscience, Rubicon, Teva Pharms Usa, and Torrent, and is included in ten NDAs. It is available from twenty-one suppliers. Additional details are available on the RABEPRAZOLE SODIUM profile page.
The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
The generic ingredient in RABEPRAZOLE SODIUM is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 205761
| Tradename: | RABEPRAZOLE SODIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | rabeprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 205761
| Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 205761
Suppliers and Packaging for NDA: 205761
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 205761 | ANDA | Aurobindo Pharma Limited | 65862-721 | 65862-721-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-721-30) |
| RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 205761 | ANDA | Aurobindo Pharma Limited | 65862-721 | 65862-721-90 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-721-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Feb 17, 2017 | TE: | AB | RLD: | No | ||||
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