Details for New Drug Application (NDA): 074473
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NDA 074473 describes TOLMETIN SODIUM, which is a drug marketed by Ani Pharms, Chartwell Rx, Rising, Sun Pharm Industries, Teva, and Cosette, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the TOLMETIN SODIUM profile page.
The generic ingredient in TOLMETIN SODIUM is tolmetin sodium. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.
The generic ingredient in TOLMETIN SODIUM is tolmetin sodium. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.
Summary for 074473
| Tradename: | TOLMETIN SODIUM |
| Applicant: | Rising |
| Ingredient: | tolmetin sodium |
| Patents: | 0 |
Pharmacology for NDA: 074473
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074473
Suppliers and Packaging for NDA: 074473
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLMETIN SODIUM | tolmetin sodium | TABLET;ORAL | 074473 | ANDA | Rising Pharma Holdings, Inc. | 16571-825 | 16571-825-09 | 90 TABLET, FILM COATED in 1 BOTTLE (16571-825-09) |
| TOLMETIN SODIUM | tolmetin sodium | TABLET;ORAL | 074473 | ANDA | Poly Pharmaceuticals, Inc. | 50991-988 | 50991-988-30 | 30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE | ||||
| Approval Date: | Aug 30, 1994 | TE: | RLD: | No | |||||
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