Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018679
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/30/1982 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
06/13/2016 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018679Orig1s044ltr.pdf
08/11/2016 SUPPL-43

Label is not available on this site.

07/12/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf
02/11/2008 SUPPL-38 Labeling

Label is not available on this site.

06/18/2003 SUPPL-34 Labeling

Label is not available on this site.

05/15/2002 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/15/2002 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/15/2002 SUPPL-31 Labeling

Label is not available on this site.

05/15/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2002 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

05/15/2002 SUPPL-28 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/07/2000 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

03/06/1997 SUPPL-25 Labeling

Label is not available on this site.

04/16/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/05/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/17/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/17/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/14/1989 SUPPL-17 Labeling

Label is not available on this site.

03/01/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/27/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/27/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/08/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/19/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/18/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/06/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/06/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/07/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2016 SUPPL-44 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf
07/12/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf

TRIMETHOPRIM

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription Yes AB 018679 MAYNE PHARMA
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription No AB 091437 NOVEL LABS INC
TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Prescription No AB 070049 WATSON LABS

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