Drugs@FDA: FDA-Approved Drugs
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFATRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Discontinued | None | No | No |
| SULFATRIM PEDIATRIC | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/07/1983 | 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 |
|---|---|---|---|---|---|
| 10/15/2021 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018615s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018615Orig1s080ltr.pdf | |
| 09/07/2016 | SUPPL-76 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
Label is not available on this site. |
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| 09/25/2003 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 02/07/2001 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/13/2000 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/21/1997 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 06/20/1997 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1997 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/08/1995 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1994 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 02/16/1994 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 11/03/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1993 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1993 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1993 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/05/1993 | SUPPL-32 | Bioequivalence |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1991 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/22/1993 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1990 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 01/12/1990 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/01/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/14/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1986 | SUPPL-6 | 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 |
|---|---|---|---|---|---|
| 10/15/2021 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018615s080lbl.pdf |
SULFATRIM
There are no Therapeutic Equivalents.
SULFATRIM PEDIATRIC
SUSPENSION;ORAL; 200MG/5ML;40MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 091348 | AUROBINDO PHARMA |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 077785 | CHARTWELL MOLECULAR |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 214330 | NOVITIUM PHARMA |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 077612 | PRASCO |
| SULFATRIM PEDIATRIC | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 018615 | PHARM ASSOC |