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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020457
Company: CHEPLAPHARM

Products on NDA 020457

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETOPOPHOS PRESERVATIVE FREE	ETOPOSIDE PHOSPHATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020457

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1996	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2019	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020457s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020457Orig1s019ltr.pdf
05/23/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020457s016lbl.pdf
11/09/2016	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020457s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020457Orig1s015ltr.pdf
07/30/2015	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020457s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020457Orig1s014ltr.pdf
03/17/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020457s013ltr.pdf
11/05/2002	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457slr006,20906slr002ltr.pdf
08/16/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/21/2002	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf
02/21/2002	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457s3s4ltr.pdf
12/21/2001	SUPPL-2	Labeling		Label is not available on this site.

Labels for NDA 020457

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020457s019lbl.pdf
05/23/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020457s016lbl.pdf
11/09/2016	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020457s015lbl.pdf
07/30/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020457s014lbl.pdf
03/17/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf

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