Details for New Drug Application (NDA): 021042
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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: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | May 20, 1999 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 20, 1999 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 25, 2000 | TE: | RLD: | No | |||||
Expired US Patents for NDA 021042
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-001 | May 20, 1999 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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