Details for New Drug Application (NDA): 207237
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NDA 207237 describes CARISOPRODOL, which is a drug marketed by Able, Accelrx Labs, Aurobindo Pharma, Chartwell Rx, Epic Pharma Llc, Fosun Wanbang, Heritage, Hikma Intl Pharms, Mpp Pharma, Natco, Novast Labs, Orient Pharma Co Ltd, Oxford Pharms, Pioneer Pharms, Pointview Hldings, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Chartwell, 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 207237
| Tradename: | CARISOPRODOL |
| Applicant: | Mpp Pharma |
| Ingredient: | carisoprodol |
| Patents: | 0 |
Pharmacology for NDA: 207237
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 207237
Suppliers and Packaging for NDA: 207237
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARISOPRODOL | carisoprodol | TABLET;ORAL | 207237 | ANDA | Nostrum Laboratories, Inc. | 29033-207 | 29033-207-01 | 100 TABLET in 1 BOTTLE (29033-207-01) |
| CARISOPRODOL | carisoprodol | TABLET;ORAL | 207237 | ANDA | Nostrum Laboratories, Inc. | 29033-214 | 29033-214-01 | 100 TABLET in 1 BOTTLE (29033-214-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | May 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 350MG | ||||
| Approval Date: | Sep 21, 2020 | TE: | AA | RLD: | No | ||||
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