Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIMETHOPRIM | TRIMETHOPRIM | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
06/18/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/27/2012 | SUPPL-27 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/071259s027lbl.pdf | |
05/15/2002 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
05/15/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/15/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/15/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/15/2002 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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07/07/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/16/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/06/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
04/16/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/05/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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07/17/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/17/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/10/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/27/2012 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/071259s027lbl.pdf |