Details for New Drug Application (NDA): 021052
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The generic ingredient in VIOXX is rofecoxib. There are two drug master file entries for this compound. Additional details are available on the rofecoxib profile page.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 12.5MG/5ML | ||||
Approval Date: | May 20, 1999 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
Approval Date: | May 20, 1999 | TE: | RLD: | No |
Expired US Patents for NDA 021052
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-001 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-002 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-002 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Merck | VIOXX | rofecoxib | SUSPENSION;ORAL | 021052-002 | May 20, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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