Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077612
Company: PRASCO
Company: PRASCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFAMETHOXAZOLE AND TRIMETHOPRIM | 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 |
---|---|---|---|---|---|---|---|
11/13/2006 | 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 |
---|---|---|---|---|---|
09/12/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2012 | SUPPL-5 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077612s005lbl.pdf | |
11/01/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
05/31/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/13/2012 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077612s005lbl.pdf |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
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 |