An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
11/20/2024	SUPPL-52	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020800s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020800Orig1s052ltr.pdf
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-Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient 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
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

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.

Top