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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075547
Company: WEST-WARD PHARMS INT

Products on ANDA 075547

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075547

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.html

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

Labels for ANDA 075547

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

Therapeutic Equivalents for ANDA 075547

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	208242	PENN LIFE
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211831	REGCON HOLDINGS
THIOTEPA	THIOTEPA	15MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	075547	WEST-WARD PHARMS INT

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