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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204200
Company: PAR STERILE PRODUCTS

Summary Review

Products on NDA 204200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADRENALIN	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2012	ORIG-2	Approval	Efficacy	PRIORITY		Label is not available on this site.
12/07/2012	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/2012/204200s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204200Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200_adrenalin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204200Orig1Orig2s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2023	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204200Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204200Orig1s018ltr.pdf
01/29/2019	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204200Orig1s009,204640Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204200Orig1s009,204640Orig1s009ltr.pdf
08/09/2017	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204200Orig1s007,204640Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204200Orig1s007.pdf
05/18/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640Orig1s003ltr.pdf
09/12/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s004ltr.pdf
03/03/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/31/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204200

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/05/2023	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204200Orig1s018lbl.pdf
01/05/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204200Orig1s018lbl.pdf
01/29/2019	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204200Orig1s009,204640Orig1s009lbl.pdf
08/09/2017	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf
09/12/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200Orig1s004lbl.pdf
05/18/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf
12/07/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204200s000lbl.pdf

Therapeutic Equivalents for NDA 204200

ADRENALIN

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; EQ 1MG BASE/ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADRENALIN	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	204200	PAR STERILE PRODUCTS
EPINEPHRINE	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207568	AM REGENT

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