Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050263
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE 125MG/5ML SUSPENSION;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
01/27/1955 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
03/22/1983 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1982 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1979 SUPPL-65 Labeling

Label is not available on this site.

10/11/1978 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1976 SUPPL-63 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/19/1973 SUPPL-62 Labeling

Label is not available on this site.

09/05/1972 SUPPL-61 Labeling

Label is not available on this site.

09/29/1971 SUPPL-60 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/02/1971 SUPPL-59 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/26/1971 SUPPL-58 Labeling

Label is not available on this site.

07/14/1971 SUPPL-57 Labeling

Label is not available on this site.

10/26/1970 SUPPL-56 Labeling

Label is not available on this site.

01/05/1970 SUPPL-55 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/23/1969 SUPPL-54 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/12/1968 SUPPL-53 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/24/1967 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/17/1966 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/17/1966 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/29/1965 SUPPL-47 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/18/1964 SUPPL-46 Labeling

Label is not available on this site.

08/10/1964 SUPPL-45 Labeling

Label is not available on this site.

06/23/1964 SUPPL-44 Labeling

Label is not available on this site.

06/19/1964 SUPPL-43 Labeling

Label is not available on this site.

10/18/1963 SUPPL-40 Efficacy-New Indication

Label is not available on this site.

10/18/1963 SUPPL-39 Labeling

Label is not available on this site.

06/18/1963 SUPPL-38 Labeling

Label is not available on this site.

06/04/1963 SUPPL-37 Labeling

Label is not available on this site.

05/27/1963 SUPPL-36 Labeling

Label is not available on this site.

04/16/1962 SUPPL-34 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/13/1962 SUPPL-33 Labeling

Label is not available on this site.

02/13/1962 SUPPL-32 Labeling

Label is not available on this site.

10/30/1961 SUPPL-31 Labeling

Label is not available on this site.

07/24/1961 SUPPL-30 Labeling

Label is not available on this site.

05/31/1961 SUPPL-29 Labeling

Label is not available on this site.

03/17/1961 SUPPL-28 Labeling

Label is not available on this site.

03/15/1961 SUPPL-27 Labeling

Label is not available on this site.

02/17/1961 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/31/1961 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/22/1960 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/01/1958 SUPPL-23 Labeling

Label is not available on this site.

09/15/1958 SUPPL-22 Labeling

Label is not available on this site.

06/13/1958 SUPPL-21 Labeling

Label is not available on this site.

04/17/1958 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/1958 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/19/1959 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/18/1957 SUPPL-17 Labeling

Label is not available on this site.

10/18/1957 SUPPL-16 Labeling

Label is not available on this site.

06/25/1957 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/25/1957 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1957 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1957 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1957 SUPPL-10 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.

07/13/1955 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1955 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1955 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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