Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074650
Company: HI TECH PHARMA
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
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 074650 HI TECH PHARMA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 077785 LANNETT CO INC
SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION;ORAL Prescription No AB 018615 PHARM ASSOC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English