Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050257
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECLOMYCIN DEMECLOCYCLINE HYDROCHLORIDE 75MG/5ML SYRUP;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
11/14/1960 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
09/25/1978 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-55 Labeling

Label is not available on this site.

02/28/1976 SUPPL-54 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/28/1974 SUPPL-53 Labeling

Label is not available on this site.

10/10/1973 SUPPL-52 Labeling

Label is not available on this site.

10/01/1973 SUPPL-51 Labeling

Label is not available on this site.

02/22/1972 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/10/1972 SUPPL-49 Labeling

Label is not available on this site.

01/10/1972 SUPPL-48 Labeling

Label is not available on this site.

07/14/1971 SUPPL-47 Labeling

Label is not available on this site.

10/18/1970 SUPPL-46 Labeling

Label is not available on this site.

04/24/1970 SUPPL-45 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/13/1971 SUPPL-44 Labeling

Label is not available on this site.

02/10/1970 SUPPL-43 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/12/1969 SUPPL-42 Labeling

Label is not available on this site.

08/29/1969 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/12/1969 SUPPL-40 Labeling

Label is not available on this site.

10/26/1967 SUPPL-39 Labeling

Label is not available on this site.

09/21/1967 SUPPL-38 Labeling

Label is not available on this site.

04/05/1967 SUPPL-37 Labeling

Label is not available on this site.

12/30/1966 SUPPL-35 Labeling

Label is not available on this site.

11/04/1966 SUPPL-34 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/15/1966 SUPPL-33 Labeling

Label is not available on this site.

10/21/1966 SUPPL-31 Labeling

Label is not available on this site.

01/05/1966 SUPPL-30 Labeling

Label is not available on this site.

01/26/1965 SUPPL-29 Labeling

Label is not available on this site.

12/14/1964 SUPPL-28 Labeling

Label is not available on this site.

12/14/1964 SUPPL-27 Labeling

Label is not available on this site.

08/17/1964 SUPPL-26 Labeling

Label is not available on this site.

07/14/1964 SUPPL-25 Labeling

Label is not available on this site.

06/23/1964 SUPPL-24 Labeling

Label is not available on this site.

01/23/1964 SUPPL-23 Labeling

Label is not available on this site.

01/15/1964 SUPPL-22 Labeling

Label is not available on this site.

01/08/1964 SUPPL-21 Labeling

Label is not available on this site.

11/12/1963 SUPPL-20 Labeling

Label is not available on this site.

05/27/1963 SUPPL-19 Labeling

Label is not available on this site.

05/27/1963 SUPPL-18 Labeling

Label is not available on this site.

01/03/1963 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1962 SUPPL-15 Labeling

Label is not available on this site.

06/27/1962 SUPPL-13 Labeling

Label is not available on this site.

06/27/1962 SUPPL-12 Labeling

Label is not available on this site.

07/26/1962 SUPPL-11 Labeling

Label is not available on this site.

07/26/1962 SUPPL-10 Labeling

Label is not available on this site.

07/26/1962 SUPPL-9 Labeling

Label is not available on this site.

04/11/1962 SUPPL-8 Labeling

Label is not available on this site.

02/09/1962 SUPPL-7 Labeling

Label is not available on this site.

10/30/1961 SUPPL-6 Labeling

Label is not available on this site.

10/21/1961 SUPPL-5 Labeling

Label is not available on this site.

05/16/1961 SUPPL-4 Labeling

Label is not available on this site.

04/05/1961 SUPPL-3 Labeling

Label is not available on this site.

11/28/1960 SUPPL-2 Labeling

Label is not available on this site.

11/28/1960 SUPPL-1 Labeling

Label is not available on this site.

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