Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073303
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE;INJECTION Prescription AP 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
10/31/1991 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
04/29/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf
02/27/2013 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

04/29/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

07/23/2002 SUPPL-8 Labeling

Label is not available on this site.

08/26/1998 SUPPL-7 Labeling

Label is not available on this site.

12/27/1996 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/26/1993 SUPPL-4 Labeling

Label is not available on this site.

11/03/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/05/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/07/1992 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
04/29/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/073303s030lbl.pdf

SULFAMETHOXAZOLE AND TRIMETHOPRIM

INJECTABLE;INJECTION; 80MG/ML;16MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE;INJECTION Prescription No AP 206607 MYLAN LABS LTD
SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE;INJECTION Prescription No AP 073303 TEVA PHARMS USA

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