Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050276
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACHROMYCIN PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE 40MG/VIAL;100MG/VIAL INJECTABLE;INJECTION Discontinued None No No
ACHROMYCIN PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE 40MG/VIAL;250MG/VIAL INJECTABLE;INJECTION 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
07/01/1954 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
10/09/1986 SUPPL-45 Labeling

Label is not available on this site.

09/30/1985 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1984 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

07/24/1984 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1982 SUPPL-40 Labeling

Label is not available on this site.

05/12/1981 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1981 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1979 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-36 Labeling

Label is not available on this site.

01/13/1975 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1974 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1973 SUPPL-33 Labeling

Label is not available on this site.

10/21/1973 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/05/1971 SUPPL-31 Labeling

Label is not available on this site.

06/21/1973 SUPPL-30 Labeling

Label is not available on this site.

01/05/1966 SUPPL-28 Labeling

Label is not available on this site.

08/12/1964 SUPPL-27 Labeling

Label is not available on this site.

10/24/1963 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/27/1963 SUPPL-25 Labeling

Label is not available on this site.

10/30/1961 SUPPL-22 Labeling

Label is not available on this site.

04/07/1961 SUPPL-21 Labeling

Label is not available on this site.

03/13/1961 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1960 SUPPL-19 Labeling

Label is not available on this site.

07/31/1959 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1959 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1960 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1958 SUPPL-15 Labeling

Label is not available on this site.

08/18/1958 SUPPL-14 Labeling

Label is not available on this site.

07/18/1955 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1991 SUPPL-10 Labeling

Label is not available on this site.

11/20/1991 SUPPL-8 Labeling

Label is not available on this site.

11/20/1991 SUPPL-7 Labeling

Label is not available on this site.

04/19/1957 SUPPL-6 Labeling

Label is not available on this site.

03/04/1955 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1954 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1954 SUPPL-2 Labeling

Label is not available on this site.

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