Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020463
Company: BLACKSMITH BRANDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NASALCROM CROMOLYN SODIUM 5.2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED;NASAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/03/1997 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch 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
07/15/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20463s008ltr.pdf
11/27/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/12/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2001 SUPPL-2 Efficacy-New Patient Population Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20463S2LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-463S002_NasalCrom.cfm
11/04/1998 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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