Details for New Drug Application (NDA): 040823
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NDA 040823 describes CARISOPRODOL, which is a drug marketed by Able, Accelrx Labs, Allied, Aurobindo Pharma, Chartwell Rx, Epic Pharma Llc, Hikma Intl Pharms, Natco, Nostrum Labs Inc, Novast Labs, Orient Pharma Co Ltd, Oxford Pharms, Pioneer Pharms, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Wanbang Biopharms, Watson Labs, Watson Labs Teva, Genus, and Ingenus Pharms Nj, and is included in thirty-two NDAs. It is available from twenty-five suppliers. Additional details are available on the CARISOPRODOL profile page.
The generic ingredient in CARISOPRODOL is aspirin; carisoprodol; codeine phosphate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; carisoprodol; codeine phosphate profile page.
The generic ingredient in CARISOPRODOL is aspirin; carisoprodol; codeine phosphate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; carisoprodol; codeine phosphate profile page.
Summary for 040823
| Tradename: | CARISOPRODOL |
| Applicant: | Novast Labs |
| Ingredient: | carisoprodol |
| Patents: | 0 |
Pharmacology for NDA: 040823
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 040823
Suppliers and Packaging for NDA: 040823
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARISOPRODOL | carisoprodol | TABLET;ORAL | 040823 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-656 | 50742-656-01 | 100 TABLET in 1 BOTTLE (50742-656-01) |
| CARISOPRODOL | carisoprodol | TABLET;ORAL | 040823 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-656 | 50742-656-05 | 500 TABLET in 1 BOTTLE (50742-656-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 350MG | ||||
| Approval Date: | Oct 22, 2008 | TE: | AA | RLD: | No | ||||
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