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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201370
Company: PFIZER

Summary Review

Products on NDA 201370

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201370

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.
03/03/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/22/2014	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
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.

Labels for NDA 201370

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

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