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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205029
Company: BPI LABS

Products on NDA 205029

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Prescription	None	Yes	Yes
EPINEPHRINE	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes
EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205029

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2014	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205029Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205029Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2023	SUPPL-13	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205029Orig1s013Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205029Orig1s013Correctedltr.pdf
05/12/2023	SUPPL-10	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205029Orig1s010ltr.pdf
02/04/2022	SUPPL-9	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205029Orig1s009ltr.pdf
06/23/2021	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205029Orig1s008ltr.pdf
09/10/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205029Orig1s006ltr.pdf
05/18/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s004ltr.pdf
12/03/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/11/2016	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s002ltr.pdf
10/23/2015	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205029Orig1s001ltr.pdf

Labels for NDA 205029

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/2023	SUPPL-13	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205029Orig1s013Correctedlbl.pdf
05/12/2023	SUPPL-10	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029s010lbl.pdf
02/04/2022	SUPPL-9	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205029Orig1s009lbl.pdf
09/10/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029s006lbl.pdf
06/23/2021	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf
06/23/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf
05/18/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf
02/11/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf
10/23/2015	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf
07/29/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf

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