Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019722
Company: PAR PHARM

Products on NDA 019722

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NASCOBAL	CYANOCOBALAMIN	0.5MG/INH	GEL, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019722

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/1996	ORIG-1	Approval	Type 3 - New Dosage Form	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
08/21/2003	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19722slr006ltr.pdf
06/14/2002	SUPPL-4	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19722s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019722_S004_NASCOBAL GEL.pdf
05/04/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/22/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/22/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019722

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2003	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19722slr006_nascobal_lbl.pdf