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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019557
Company: STRIDES PHARMA

Products on NDA 019557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VEPESID	ETOPOSIDE	50MG	CAPSULE;ORAL	Discontinued	None	Yes	No
VEPESID	ETOPOSIDE	100MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019557

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1986	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2002	SUPPL-28	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18768slr045,19557slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019557_S028_VEPESIDE.pdf
11/21/2000	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
02/02/2000	SUPPL-26	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/02/1999	SUPPL-23	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19557S023_VePesid.pdf
01/19/1999	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/15/1998	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
10/17/1995	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
07/23/1993	SUPPL-15	Labeling		Label is not available on this site.
03/02/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/17/1995	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1991	SUPPL-10	Labeling		Label is not available on this site.
11/01/1991	SUPPL-9	Labeling		Label is not available on this site.
07/14/1989	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/1988	SUPPL-6	Labeling		Label is not available on this site.
08/24/1987	SUPPL-5	Labeling		Label is not available on this site.
08/24/1987	SUPPL-4	Labeling		Label is not available on this site.
05/20/1987	SUPPL-3	Labeling		Label is not available on this site.
03/26/1987	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 019557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2002	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/019557s028lbl.pdf

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