An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022102
Company: PAR PHARM

Summary Review

Products on NDA 022102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALOMIST	CYANOCOBALAMIN	25MCG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022102s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022102_calomist_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022102s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022102s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022102Orig1s004ltr.pdf
03/24/2009	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022102s003ltr.pdf

Labels for NDA 022102

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022102s004lbl.pdf
03/24/2009	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf
03/24/2009	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf
07/27/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022102s000lbl.pdf

Top