Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075635
Company: MYLAN

Products on ANDA 075635

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETOPOSIDE	ETOPOSIDE	50MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075635

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75635.ap..pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/75-635_Etoposide.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2018	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/29/2006	SUPPL-8	Labeling		Label is not available on this site.
05/28/2004	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075635

ETOPOSIDE

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETOPOSIDE	ETOPOSIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	075635	MYLAN
VEPESID	ETOPOSIDE	50MG	CAPSULE;ORAL	Prescription	Yes	AB	019557	ONESOURCE SPECIALTY