Drugs@FDA: FDA-Approved Drugs
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CAPASTAT SULFATE | CAPREOMYCIN SULFATE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/02/1971 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/17/2023 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050095s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050095Orig1s078ltr.pdf | |
10/01/2019 | SUPPL-74 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050095Orig1s074ltr.pdf |
01/16/2019 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050095s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050095Orig1s072ltr.pdf | |
07/24/2008 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050095s062ltr.pdf |
06/11/2003 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50095slr044ltr.pdf | |
10/05/2001 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/21/1995 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1996 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
08/12/1987 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
07/08/1987 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
05/26/1987 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
03/06/1987 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/18/1985 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/1983 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/23/1983 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
08/05/1983 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
08/31/1982 | SUPPL-30 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
04/12/1982 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/29/1981 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
03/04/1981 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/1981 | SUPPL-25 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
06/03/1980 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
01/25/1980 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
11/03/1978 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/21/1977 | SUPPL-21 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/12/1977 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
12/03/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
09/14/1976 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
10/28/1975 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
09/23/1975 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/20/1974 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/28/1973 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
07/18/1973 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
08/29/1972 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
02/25/1972 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
12/20/1971 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/12/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
05/26/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/08/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/26/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
12/09/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
01/18/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
09/26/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/23/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
08/05/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/17/2023 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050095s078lbl.pdf | |
01/16/2019 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050095s072lbl.pdf | |
07/24/2008 | SUPPL-62 | Labeling | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf |
06/11/2003 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf |