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Drugs@FDA: FDA-Approved Drugs

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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SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
05/21/2021 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018374s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018374Orig1s028ltr.pdf
07/29/2020 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018374Orig1s027ltr.pdf
02/09/2018 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018374s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018374Orig1s026ltr.pdf
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
05/21/2021 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018374s028lbl.pdf
07/29/2020 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf
02/09/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018374s026lbl.pdf
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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