Drugs@FDA: FDA-Approved Drugs
Company: COREPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECLOMYCIN | DEMECLOCYCLINE HYDROCHLORIDE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| DECLOMYCIN | DEMECLOCYCLINE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| DECLOMYCIN | DEMECLOCYCLINE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 09/22/1964 | 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 |
|---|---|---|---|---|---|
| 09/05/2012 | SUPPL-101 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050261s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050261Orig1s101ltr.pdf | |
| 04/22/2008 | SUPPL-100 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050261s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050261s100ltr.pdf | |
| 12/18/2003 | SUPPL-97 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr094ltr.pdf |
| 05/01/2003 | SUPPL-95 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr095ltr.pdf |
| 12/18/2003 | SUPPL-94 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr094ltr.pdf |
| 12/07/2000 | SUPPL-93 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1999 | SUPPL-92 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1997 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1997 | SUPPL-90 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1982 | SUPPL-89 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/08/1980 | SUPPL-88 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1979 | SUPPL-87 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/1978 | SUPPL-86 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/14/1978 | SUPPL-85 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/07/1978 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 08/25/1976 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1976 | SUPPL-82 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/22/1976 | SUPPL-81 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1975 | SUPPL-80 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/08/1975 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1974 | SUPPL-78 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/28/1974 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 01/10/1974 | SUPPL-76 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/01/1973 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 10/01/1973 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 10/01/1973 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 02/16/1972 | SUPPL-72 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/16/1972 | SUPPL-71 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/16/1972 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 01/10/1972 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 01/10/1972 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 01/10/1972 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 07/14/1971 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 06/14/1971 | SUPPL-65 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/01/1970 | SUPPL-64 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/23/1970 | SUPPL-63 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/23/1970 | SUPPL-62 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/14/1970 | SUPPL-61 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/03/1969 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1967 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 11/17/1967 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 04/25/1967 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 04/25/1967 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 04/25/1967 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 02/15/1967 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 02/20/1967 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 12/29/1966 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/29/1966 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/29/1966 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 09/28/1966 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 09/28/1966 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/05/1966 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 09/15/1966 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/06/1966 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/03/1966 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/04/1966 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/25/1966 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/11/1966 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/18/1966 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/14/1966 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/05/1966 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/05/1966 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/22/1965 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/13/1966 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/13/1966 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/07/1965 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/13/1965 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/23/1965 | SUPPL-19 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 08/19/1965 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/24/1965 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1965 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1965 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1965 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/20/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/17/1987 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/09/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/10/1965 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/21/1983 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 09/05/2012 | SUPPL-101 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050261s101lbl.pdf | |
| 04/22/2008 | SUPPL-100 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050261s100lbl.pdf |