Details for New Drug Application (NDA): 040188
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NDA 040188 describes CARISOPRODOL, which is a drug marketed by Able, Accelrx Labs, Aurobindo Pharma, Chartwell Rx, Epic Pharma Llc, Heritage, Hikma Intl Pharms, Ingenus Pharms Llc, Mpp Pharma, Natco, Orient Pharma Co Ltd, Oxford Pharms, Pioneer Pharms, Pointview Hldings, Sandoz, Sciegen Pharms, Senores Pharms, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Genus, and Ingenus Pharms Nj, and is included in thirty-two NDAs. It is available from twenty-four 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 040188
| Tradename: | CARISOPRODOL |
| Applicant: | Oxford Pharms |
| Ingredient: | carisoprodol |
| Patents: | 0 |
Pharmacology for NDA: 040188
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 040188
Suppliers and Packaging for NDA: 040188
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARISOPRODOL | carisoprodol | TABLET;ORAL | 040188 | ANDA | Medsource Pharmaceuticals | 45865-233 | 45865-233-30 | 30 TABLET in 1 BOTTLE (45865-233-30) |
| CARISOPRODOL | carisoprodol | TABLET;ORAL | 040188 | ANDA | Medsource Pharmaceuticals | 45865-233 | 45865-233-60 | 60 TABLET in 1 BOTTLE (45865-233-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 350MG | ||||
| Approval Date: | Mar 7, 1997 | TE: | AA | RLD: | No | ||||
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