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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020800
Company: IMPAX

Products on NDA 020800

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 0.15	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No
TWINJECT 0.3	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020800

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20800ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-800_Twinject.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2021	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020800s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020800Orig1s040ltr.pdf
08/29/2018	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020800s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020800Orig1s035ltr.pdf
05/18/2016	SUPPL-34	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020800Orig1s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020800Orig1s034pkg.pdf
10/17/2014	SUPPL-30	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s030ltr.pdf
10/13/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
10/23/2014	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
07/25/2014	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s027ltr.pdf
03/25/2014	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/24/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
04/23/2014	SUPPL-24	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s024ltr.pdf
09/06/2013	SUPPL-23	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf
01/26/2011	SUPPL-20	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020800s020ltr.pdf
11/25/2009	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf
12/28/2006	SUPPL-11	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020800s011ltr.pdf
07/01/2005	SUPPL-7	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s007ltr.pdf
07/07/2005	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s006ltr.pdf
02/22/2005	SUPPL-5	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20800s005ltr.pdf
05/28/2004	SUPPL-1	Efficacy-New Patient Population	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20800se5-001ltr.pdf

Labels for NDA 020800

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-Patient 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-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

Therapeutic Equivalents for NDA 020800

ADRENACLICK

There are no Therapeutic Equivalents.

TWINJECT 0.15

There are no Therapeutic Equivalents.

TWINJECT 0.3

There are no Therapeutic Equivalents.

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