Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022368
Company: PHARMAXIS LTD
Company: PHARMAXIS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARIDOL | MANNITOL | 10MG | POWDER; INHALATION | Prescription | None | TBD | No |
| ARIDOL | MANNITOL | 20MG | POWDER; INHALATION | Prescription | None | TBD | No |
| ARIDOL | MANNITOL | 40MG | POWDER; INHALATION | Prescription | None | TBD | No |
| ARIDOL KIT | MANNITOL | N/A,5MG,10MG,20MG,40MG | POWDER;INHALATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/05/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022368S000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022368s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368_aridol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2021 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022368s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022368Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/13/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022368s003lbl.pdf | |
| 10/05/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022368S000lbl.pdf |
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