Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050262
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECLOMYCIN DEMECLOCYCLINE HYDROCHLORIDE 150MG CAPSULE;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
01/14/1960 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
02/28/1974 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1973 SUPPL-60 Labeling

Label is not available on this site.

03/26/1982 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1979 SUPPL-58 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/26/1976 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1976 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1975 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1972 SUPPL-54 Labeling

Label is not available on this site.

02/10/1972 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1969 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1967 SUPPL-50 Labeling

Label is not available on this site.

07/13/1967 SUPPL-49 Labeling

Label is not available on this site.

07/13/1967 SUPPL-48 Labeling

Label is not available on this site.

01/05/1966 SUPPL-47 Labeling

Label is not available on this site.

09/28/1966 SUPPL-46 Labeling

Label is not available on this site.

10/19/1965 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1965 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1965 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1965 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1965 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1965 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1965 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/20/1972 SUPPL-38 Labeling

Label is not available on this site.

07/13/1971 SUPPL-37 Labeling

Label is not available on this site.

09/14/1967 SUPPL-36 Labeling

Label is not available on this site.

06/16/1967 SUPPL-35 Labeling

Label is not available on this site.

12/28/1965 SUPPL-34 Labeling

Label is not available on this site.

09/03/1965 SUPPL-33 Labeling

Label is not available on this site.

03/16/1965 SUPPL-32 Labeling

Label is not available on this site.

08/13/1964 SUPPL-31 Labeling

Label is not available on this site.

06/09/1964 SUPPL-30 Labeling

Label is not available on this site.

01/15/1964 SUPPL-29 Labeling

Label is not available on this site.

01/14/1964 SUPPL-28 Labeling

Label is not available on this site.

11/12/1963 SUPPL-27 Labeling

Label is not available on this site.

07/10/1963 SUPPL-26 Labeling

Label is not available on this site.

05/24/1963 SUPPL-25 Labeling

Label is not available on this site.

01/11/1962 SUPPL-24 Labeling

Label is not available on this site.

10/30/1961 SUPPL-23 Labeling

Label is not available on this site.

02/15/1960 SUPPL-21 Labeling

Label is not available on this site.

08/02/1965 SUPPL-20 Labeling

Label is not available on this site.

11/21/1963 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1961 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1961 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

08/21/1961 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

06/23/1961 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/19/1960 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/29/1960 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/12/1960 SUPPL-12 Efficacy-New Dosing Regimen

Label is not available on this site.

03/04/1960 SUPPL-11 Efficacy-New Dosing Regimen

Label is not available on this site.

11/20/1991 SUPPL-8 Labeling

Label is not available on this site.

11/20/1991 SUPPL-6 Labeling

Label is not available on this site.

10/09/1986 SUPPL-5 Labeling

Label is not available on this site.

06/21/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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