اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CAPASTAT SULFATE از شرکت AKORN
New Drug Application (NDA): 050095
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPASTAT SULFATE | CAPREOMYCIN SULFATE | EQ 1GM BASE/VIAL | 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 |
|---|---|---|---|---|---|
| 10/01/2019 | SUPPL-74 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 01/16/2019 | 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 |
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