Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050315
Company: TRIAX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Discontinued None No No
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE 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
06/30/1971 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
03/30/1989 SUPPL-76 Labeling

Label is not available on this site.

07/27/1987 SUPPL-75 Efficacy-New Indication

Label is not available on this site.

05/01/1987 SUPPL-74 Labeling

Label is not available on this site.

12/02/1986 SUPPL-73 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/19/1986 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

05/23/1986 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1985 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1986 SUPPL-69 Labeling

Label is not available on this site.

11/30/1984 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1983 SUPPL-65 Labeling

Label is not available on this site.

02/28/1983 SUPPL-63 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/14/1982 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1982 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1981 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1980 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1981 SUPPL-55 Labeling

Label is not available on this site.

09/25/1979 SUPPL-54 Efficacy-New Indication

Label is not available on this site.

05/15/1979 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1979 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/26/1979 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

12/26/1978 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1978 SUPPL-49 Efficacy-New Indication

Label is not available on this site.

07/09/1978 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1978 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/28/1978 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1978 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1977 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1976 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1976 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1976 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1976 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/04/1976 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/14/1977 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1975 SUPPL-34 Labeling

Label is not available on this site.

05/21/1975 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1975 SUPPL-32 Labeling

Label is not available on this site.

11/04/1974 SUPPL-31 Labeling

Label is not available on this site.

10/24/1974 SUPPL-30 Labeling

Label is not available on this site.

09/23/1974 SUPPL-29 Labeling

Label is not available on this site.

06/19/1974 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/10/1973 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1973 SUPPL-26 Labeling

Label is not available on this site.

06/22/1973 SUPPL-24 Labeling

Label is not available on this site.

07/02/1973 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1973 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1973 SUPPL-21 Labeling

Label is not available on this site.

04/06/1973 SUPPL-20 Labeling

Label is not available on this site.

02/02/1973 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1972 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/20/1972 SUPPL-12 Labeling

Label is not available on this site.

11/20/1972 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1972 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/01/1972 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1971 SUPPL-6 Labeling

Label is not available on this site.

09/28/1971 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1971 SUPPL-3 Labeling

Label is not available on this site.

08/16/1971 SUPPL-1 Labeling

Label is not available on this site.

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