Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 204485
Company: PAR STERILE PRODUCTS
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASOSTRICT | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| VASOSTRICT | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/2014 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204485Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2019 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204485s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204485Orig1s009ltr.pdf | |
| 12/17/2016 | SUPPL-4 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204485Orig1s004.pdf | |
| 03/21/2016 | SUPPL-3 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/2044850Orig1s003.pdf | |
| 05/07/2015 | SUPPL-2 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204485Orig1s002ltr.pdf | |
| 09/18/2014 | SUPPL-1 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204485s009lbl.pdf | |
| 12/17/2016 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s004lbl.pdf |
| 03/21/2016 | SUPPL-3 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s003lbl.pdf |
| 05/07/2015 | SUPPL-2 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf |
| 09/18/2014 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf |
| 04/17/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf |
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