Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050261
Company: COREPHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECLOMYCIN DEMECLOCYCLINE HYDROCHLORIDE 75MG TABLET;ORAL Discontinued None No No
DECLOMYCIN DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET;ORAL Discontinued None No No
DECLOMYCIN DEMECLOCYCLINE HYDROCHLORIDE 300MG 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English