Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019660
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TILADE NEDOCROMIL SODIUM 1.75MG/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
12/30/1992 ORIG-1 Approval Type 1 - New Molecular Entity 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-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19660slr017ltr.pdf
01/30/1998 SUPPL-16 Labeling

Label is not available on this site.

03/06/1997 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

02/26/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/20/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/07/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/04/1996 SUPPL-11 Labeling

Label is not available on this site.

04/20/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/27/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1994 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-1 Efficacy-Accelerated Approval Confirmatory Study

Label is not available on this site.

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