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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018584
Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BECONASE BECLOMETHASONE DIPROPIONATE 0.042MG/INH AEROSOL, METERED;NASAL 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
09/30/1981 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
02/20/2002 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
08/31/2001 SUPPL-27 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf
12/16/2002 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18584slr026ltr.pdf
04/04/1996 SUPPL-25 Labeling

Label is not available on this site.
03/12/1996 SUPPL-23 Labeling

Label is not available on this site.
07/06/1993 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/10/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
11/19/1993 SUPPL-18 Labeling

Label is not available on this site.
12/15/1988 SUPPL-16 Labeling

Label is not available on this site.
04/27/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
12/02/1987 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/06/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
10/04/1985 SUPPL-11 Labeling

Label is not available on this site.
10/04/1985 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/01/1985 SUPPL-9 Efficacy-New Indication

Label is not available on this site.
11/01/1985 SUPPL-8 Labeling

Label is not available on this site.
09/15/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
03/01/1984 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/01/1984 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.
02/24/1988 SUPPL-4 Labeling

Label is not available on this site.
02/16/1988 SUPPL-2 Labeling

Label is not available on this site.
02/16/1988 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
08/31/2001 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf
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