Drugs@FDA: FDA-Approved Drugs
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLY-MYCIN S | COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | SUSPENSION/DROPS;OTIC | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/17/1962 | 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 |
|---|---|---|---|---|---|
| 01/05/2019 | SUPPL-59 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050356s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050356Orig1s059ltr.pdf | |
| 03/29/2016 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2013 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/2009 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050356s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050356s050ltr.pdf | |
| 12/05/2001 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/27/2001 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/2002 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50356s45ltr.pdf |
| 08/02/1994 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 08/03/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1982 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1982 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/1981 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1980 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 10/17/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 07/19/1978 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/18/1976 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/16/1972 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/20/1968 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/24/1967 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1967 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/1967 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/18/1967 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/08/1967 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/31/1967 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/31/1967 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/21/1966 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/31/1966 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1966 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1966 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1966 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/07/1966 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/15/1965 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/14/1965 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/27/1965 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/16/1965 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/26/1965 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/20/1964 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1964 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1964 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/16/1964 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1986 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/17/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1984 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/13/1983 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/28/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/05/2019 | SUPPL-59 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050356s059lbl.pdf | |
| 01/05/2019 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050356s059lbl.pdf | |
| 06/02/2009 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050356s050lbl.pdf |