Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074650
Company: HIKMA
Company: HIKMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074650Orig1s000ChemR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/06/2022 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
12/24/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074650s010lbl.pdf | |
09/15/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
04/21/2000 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
01/24/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/24/2000 | SUPPL-1 | 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 |
---|---|---|---|---|---|
12/15/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/074650s010lbl.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 | 074650 | HIKMA |
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 |