Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018887
Company: KING PHARMS LLC

Products on NDA 018887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INTAL	CROMOLYN SODIUM	0.8MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/1985	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
02/11/2004	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18887slr020_intal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18887slr020ltr.pdf
07/23/1997	SUPPL-17	Labeling		Label is not available on this site.
12/27/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/21/1995	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/1993	SUPPL-14	Labeling		Label is not available on this site.
04/15/1988	SUPPL-10	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/31/1986	SUPPL-2	Labeling		Label is not available on this site.
01/31/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018887

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2004	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18887slr020_intal_lbl.pdf