Drugs@FDA: FDA Approved Drug Products

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

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

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