Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203697
Company: PLX PHARMA
Company: PLX PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VAZALORE | ASPIRIN | 325MG | CAPSULE;ORAL | Over-the-counter | None | Yes | Yes |
| VAZALORE | ASPIRIN | 81MG | CAPSULE;ORAL | Over-the-counter | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2013 | 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/2013/203697Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203697Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203697_aspirin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203697Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/03/2022 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203697Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203697Orig1s009ltr.pdf | |
| 11/16/2021 | SUPPL-8 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203697Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203697Orig1s008ltr.pdf | |
| 12/11/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203697Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203697Orig1s004ltr.pdf | |
| 07/25/2018 | SUPPL-3 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203697Orig1s003Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203697Orig1s003Ltr.pdf | |
| 11/20/2017 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203697Orig1s002ltr.pdf | |
| 01/03/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/03/2022 | SUPPL-9 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203697Orig1s009lbl.pdf | |
| 11/16/2021 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203697Orig1s008lbl.pdf | |
| 12/11/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203697Orig1s004lbl.pdf | |
| 12/11/2019 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203697Orig1s004lbl.pdf | |
| 07/25/2018 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203697Orig1s003Lbl.pdf | |
| 11/20/2017 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203697Orig1s002ltr.pdf | |
| 01/14/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203697Orig1s000lbl.pdf |
VAZALORE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 81MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| VAZALORE | ASPIRIN | 81MG | CAPSULE;ORAL | Over-the-counter | Yes | 203697 | PLX PHARMA |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 325MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| VAZALORE | ASPIRIN | 325MG | CAPSULE;ORAL | Over-the-counter | Yes | 203697 | PLX PHARMA |