Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORGESIC | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | 385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
NORGESIC FORTE | ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE | 770MG;60MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/04/1964 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013416s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013416Orig1s030ltr.pdf | |
03/26/1999 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/12/1997 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/13/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/16/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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03/30/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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11/05/1993 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/28/1987 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/25/2002 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13416spd021ltr.pdf |
01/31/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
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07/27/1977 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/27/1977 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013416s030lbl.pdf |