Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201370
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
07/21/2011 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201370s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201370s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201370_heparin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201370Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/19/2019 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201370Orig1s013,s014ltr.pdf | |
09/19/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201370Orig1s013,s014ltr.pdf | |
08/09/2016 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201370s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201370Orig1s010ltr.pdf | |
12/05/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/2014 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/22/2014 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/11/2012 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/19/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf | |
09/19/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201370s013s014lbl.pdf | |
08/09/2016 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201370s010lbl.pdf | |
07/21/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201370s000lbl.pdf |