Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075547
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOTEPA THIOTEPA 15MG/VIAL 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
04/02/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75547ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2015 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/075547Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/075547Orig1s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/08/2015 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/075547Orig1s006lbl.pdf
04/02/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa_prntlbl.pdf

THIOTEPA

INJECTABLE;INJECTION; 15MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOTEPA THIOTEPA 15MG/VIAL INJECTABLE;INJECTION Prescription No AP 210337 DR REDDYS
THIOTEPA THIOTEPA 15MG/VIAL INJECTABLE;INJECTION Prescription No AP 209150 JIANGSU HENGRUI MED
THIOTEPA THIOTEPA 15MG/VIAL INJECTABLE;INJECTION Prescription No AP 075547 WEST-WARD PHARMS INT

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