Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018596
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTAL CROMOLYN SODIUM 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION Discontinued None Yes No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
05/28/1982 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

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-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18596slr030ltr.pdf
03/06/2002 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/06/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/27/1997 SUPPL-26 Labeling

Label is not available on this site.

02/26/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/18/1995 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1996 SUPPL-21 Labeling

Label is not available on this site.

08/09/1993 SUPPL-20 Labeling

Label is not available on this site.

04/15/1988 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1993 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/28/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1985 SUPPL-6 Labeling

Label is not available on this site.

08/31/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1984 SUPPL-4 Labeling

Label is not available on this site.

12/27/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1982 SUPPL-2 Labeling

Label is not available on this site.

10/11/1983 SUPPL-1 Labeling

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-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf

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