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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022028
Company: SANDOZ

Summary Review

Products on NDA 022028

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSYNTROPIN	COSYNTROPIN	0.25MG/ML (0.25MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2008	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/2008/022028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022028s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022028_cosyntropin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022028s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2021	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022028Orig1s006ltr.pdf
05/11/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022028s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022028Orig1s005ltr.pdf
08/07/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022028

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022028s005lbl.pdf
02/21/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022028lbl.pdf

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