Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020233
Company: ASTRAZENECA
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. |
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| 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. |
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| 06/02/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 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. |
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| 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. |