Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018340
Company: ROCHE PALO
Company: ROCHE PALO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AEROBID | FLUNISOLIDE | 0.25MG/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 |
|---|---|---|---|---|---|---|---|
| 08/17/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 11/26/2003 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18340slr021ltr.pdf |
| 05/08/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/17/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/26/1993 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/19/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/06/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/23/1987 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/18/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/25/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |