Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050451
Company: TRIAX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/10/1982 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/08/1995 SUPPL-25 Labeling

Label is not available on this site.

05/12/1992 SUPPL-23 Labeling

Label is not available on this site.

03/30/1989 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1987 SUPPL-15 Labeling

Label is not available on this site.

10/08/1986 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/27/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1986 SUPPL-10 Labeling

Label is not available on this site.

12/01/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1984 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/16/1983 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/25/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1983 SUPPL-3 Labeling

Label is not available on this site.

04/27/1983 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English