Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021175
Company: US ARMY
Company: US ARMY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATNAA | ATROPINE; PRALIDOXIME CHLORIDE | 2.1MG/0.7ML;600MG/2ML | INJECTABLE;INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|---|
| 01/17/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/26/2022 | SUPPL-47 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021175Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021175Orig1s047ltr.pdf | |
| 05/22/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021175s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021175Orig1s041ltr.pdf | |
| 11/03/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2002 | 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 |
|---|---|---|---|---|---|
| 05/26/2022 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021175Orig1s047lbl.pdf | |
| 05/26/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021175Orig1s047lbl.pdf | |
| 05/22/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021175s041lbl.pdf | |
| 01/17/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf |