Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020233
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RHINOCORT BUDESONIDE 0.032MG/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
02/14/1994 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
12/11/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/2000 SUPPL-9 Labeling

Label is not available on this site.

10/21/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1998 SUPPL-6 Labeling

Label is not available on this site.

06/08/1998 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/15/1996 SUPPL-4 Labeling

Label is not available on this site.

02/07/1996 SUPPL-3 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020233s003_rhinocort_toc.cfm
11/15/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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