Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075547
Company: WEST-WARD PHARMS INT
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 | 211831 | BELOTECA |
THIOTEPA | THIOTEPA | 15MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210337 | DR REDDYS |
THIOTEPA | THIOTEPA | 15MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209150 | HENGRUI PHARMA |
THIOTEPA | THIOTEPA | 15MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 208242 | PENN LIFE |
THIOTEPA | THIOTEPA | 15MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075547 | WEST-WARD PHARMS INT |