Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017560
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No
BACTRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No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
04/15/1975 ORIG-1 Approval Type 3 - New Dosage Form 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
11/09/2001 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1990 SUPPL-39 Efficacy-New Indication

Label is not available on this site.

06/04/1987 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1996 SUPPL-35 Labeling

Label is not available on this site.

08/11/1987 SUPPL-34 Labeling

Label is not available on this site.

06/10/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1985 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1984 SUPPL-30 Labeling

Label is not available on this site.

06/15/1982 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1982 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/1981 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1981 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1980 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/31/1980 SUPPL-19 Labeling

Label is not available on this site.

02/23/1982 SUPPL-18 Efficacy

Label is not available on this site.

12/17/1979 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/17/1979 SUPPL-16 Labeling

Label is not available on this site.

12/07/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1979 SUPPL-14 Labeling

Label is not available on this site.

12/07/1979 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/26/1979 SUPPL-12 Labeling

Label is not available on this site.

02/27/1979 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/14/1977 SUPPL-10 Labeling

Label is not available on this site.

04/21/1977 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1978 SUPPL-8 Labeling

Label is not available on this site.

03/01/1978 SUPPL-7 Labeling

Label is not available on this site.

08/23/1976 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/27/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1976 SUPPL-3 Labeling

Label is not available on this site.

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