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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050273
Company: LEDERLE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACHROMYCIN TETRACYCLINE HYDROCHLORIDE 250MG/VIAL INJECTABLE;INJECTION Discontinued None No No
ACHROMYCIN TETRACYCLINE HYDROCHLORIDE 500MG/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
11/19/1953 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
03/22/1982 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.
01/27/1982 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.
05/12/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
08/28/1979 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
04/12/1978 SUPPL-25 Labeling

Label is not available on this site.
04/26/1974 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
07/23/1973 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/1973 SUPPL-22 Labeling

Label is not available on this site.
08/31/1971 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
10/11/1968 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
01/27/1967 SUPPL-19 Labeling

Label is not available on this site.
09/13/1961 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
04/05/1960 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
06/09/1958 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/03/1955 SUPPL-15 Labeling

Label is not available on this site.
10/27/1954 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
04/22/1954 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
04/13/1954 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
01/26/1954 SUPPL-11 Labeling

Label is not available on this site.
11/20/1991 SUPPL-9 Labeling

Label is not available on this site.
11/15/1991 SUPPL-7 Labeling

Label is not available on this site.
11/15/1991 SUPPL-6 Labeling

Label is not available on this site.
10/16/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
10/09/1986 SUPPL-4 Labeling

Label is not available on this site.
09/30/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
01/25/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.
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