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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090589
Company: TEVA PHARMS USA

Products on ANDA 090589

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	AB	No	No
EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090589

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/2018	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/090589Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2021	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/23/2021	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/15/2020	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/18/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090589

EPINEPHRINE (AUTOINJECTOR)

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS; 0.3MG/DELIVERY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	No	AB	090589	TEVA PHARMS USA
EPIPEN	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	Yes	AB	019430	MYLAN SPECIALITY LP

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS; 0.15MG/DELIVERY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	No	AB	090589	TEVA PHARMS USA
EPIPEN JR.	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Prescription	Yes	AB	019430	MYLAN SPECIALITY LP

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