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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021642
Company: ENDO PHARMS INC

Products on NDA 021642

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NASCOBAL	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021642

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021642ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021642s000_NascobalTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2016	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
06/17/2015	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
10/30/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/06/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/06/2014	SUPPL-20		Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021642Orig1s020.pdf
12/07/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021642s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021642Orig1s019Ltr.pdf
11/15/2012	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/08/2011	SUPPL-15	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021642Orig1s015ltr.pdf
06/11/2014	SUPPL-11	Labeling		Label is not available on this site.
09/15/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021642s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021642s002ltr.pdf

Labels for NDA 021642

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021642s019lbl.pdf
06/06/2014	SUPPL-20		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021642s020lbl.pdf
12/08/2011	SUPPL-15	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021642Orig1s015lbl.pdf
09/15/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021642s002lbl.pdf
01/31/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021642lbl.pdf

Therapeutic Equivalents for NDA 021642

NASCOBAL

SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	210629	LUPIN
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	212458	PADAGIS ISRAEL
NASCOBAL	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	021642	ENDO PHARMS INC

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