Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018374
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/23/1981 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018374s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018374Orig1s025ltr.pdf
09/13/2001 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1991 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/23/1992 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1987 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1996 SUPPL-15 Labeling

Label is not available on this site.

08/11/1987 SUPPL-14 Labeling

Label is not available on this site.

08/05/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/22/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/02/1987 SUPPL-11 Labeling

Label is not available on this site.

11/23/1984 SUPPL-10 Labeling

Label is not available on this site.

04/02/1984 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1983 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1982 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018374s025lbl.pdf

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