Details for New Drug Application (NDA): 073393
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NDA 073393 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 073393
| Tradename: | TOLMETIN SODIUM |
| Applicant: | Rising |
| Ingredient: | tolmetin sodium |
| Patents: | 0 |
Pharmacology for NDA: 073393
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 073393
Suppliers and Packaging for NDA: 073393
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLMETIN SODIUM | tolmetin sodium | CAPSULE;ORAL | 073393 | ANDA | Rising Pharma Holdings, Inc. | 16571-826 | 16571-826-09 | 90 CAPSULE in 1 BOTTLE (16571-826-09) |
| TOLMETIN SODIUM | tolmetin sodium | CAPSULE;ORAL | 073393 | ANDA | Atland Pharmaceuticals, LLC | 71993-309 | 71993-309-30 | 30 CAPSULE in 1 BOTTLE (71993-309-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | May 27, 1993 | TE: | RLD: | No | |||||
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