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FDA NDA · NDA205029

EPINEPHRINE

Sponsor: BPI LABS

APPLICATION
NDA205029
TYPE
NDA
ORIGINAL APPROVAL
2014-07-29
LATEST ACTION
2025-06-30
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAOCULAR, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

EPINEPHRINE · ReferencePrescription
EPINEPHRINE 30MG/30ML (1MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
EPINEPHRINE · ReferencePrescription
EPINEPHRINE 10MG/10ML (1MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
EPINEPHRINE · ReferencePrescription
EPINEPHRINE 1MG/ML (1MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
EPINEPHRINE · ReferenceDiscontinued
EPINEPHRINE 1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
EPINEPHRINE · ReferencePrescription
EPINEPHRINE 1MG/ML (1MG/ML) · SOLUTION · INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2025-06-30Manufacturing (CMC) · Supplement 17 · standard — Label ↗AP
2024-10-25Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2024-03-04Manufacturing (CMC) · Supplement 12 · unknown — Letter ↗AP
2023-12-28Manufacturing (CMC) · Supplement 13 — Label ↗AP
2023-05-12Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2022-02-04Manufacturing (CMC) · Supplement 9 — Label ↗AP
2021-09-10Labeling · Supplement 6 · standard — Label ↗AP
2021-06-23Labeling · Supplement 8 · standard — Letter ↗AP
2016-05-18Labeling · Supplement 4 · 901 required — Label ↗AP
2016-02-11Efficacy · Supplement 2 · standard — Label ↗AP
2015-12-03Manufacturing (CMC) · Supplement 3 · standardAP
2015-10-23Efficacy · Supplement 1 · standard — Label ↗AP
2014-07-29Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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