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 | ⤷ Subscribe | ⤷ Subscribe |
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-003 | Feb 25, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-001 | May 20, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Merck | VIOXX | rofecoxib | TABLET;ORAL | 021042-002 | May 20, 1999 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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