Details for New Drug Application (NDA): 078964
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NDA 078964 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-two 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-four 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-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 078964
| Tradename: | RABEPRAZOLE SODIUM |
| Applicant: | Chartwell Rx |
| Ingredient: | rabeprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 078964
| Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 078964
Suppliers and Packaging for NDA: 078964
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 078964 | ANDA | medsource pharmaceuticals | 45865-802 | 45865-802-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-802-30) |
| RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 078964 | ANDA | medsource pharmaceuticals | 45865-802 | 45865-802-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-802-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | AB | RLD: | No | ||||
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