Drugs@FDA: FDA-Approved Drugs
Company: PARKEDALE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOROMYCETIN | CHLORAMPHENICOL SODIUM SUCCINATE | 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 |
|---|---|---|---|---|---|---|---|
| 02/20/1959 | 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 |
|---|---|---|---|---|---|
| 08/09/2005 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050155s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050155s039ltr.pdf | |
| 08/11/1999 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/08/1999 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1994 | SUPPL-35 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/16/1994 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1981 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1980 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1979 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 12/07/1978 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1978 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1978 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1977 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1977 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1977 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1977 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1974 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1975 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1973 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1966 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/25/1962 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1962 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1961 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1961 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1961 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1984 | 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 |
|---|---|---|---|---|---|
| 08/09/2005 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050155s039lbl.pdf |