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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020800
Company: IMPAX

Products on NDA 20800

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADRENACLICK	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	BX	Yes	Yes
ADRENACLICK	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	BX	Yes	Yes
TWINJECT	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No
TWINJECT	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No

Labels for NDA 020800

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2026	SUPPL-54	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020800s054lbl.pdf
03/19/2026	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020800s054lbl.pdf
11/20/2024	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020800s052lbl.pdf
11/20/2024	SUPPL-52	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020800s052lbl.pdf
02/04/2021	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020800s040lbl.pdf
08/29/2018	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020800s035lbl.pdf
05/18/2016	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf
05/18/2016	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf
10/17/2014	SUPPL-30	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf
07/25/2014	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf
04/23/2014	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf
04/23/2014	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf
01/26/2011	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
01/26/2011	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
01/26/2011	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
01/26/2011	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf
11/25/2009	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf

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