FDA NDA · NDA208609

EPHEDRINE SULFATE

Sponsor: RENEW PHARMS

APPLICATION

NDA208609

TYPE

NDA

ORIGINAL APPROVAL

2017-03-01

LATEST ACTION

2024-06-10

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

EPHEDRINE SULFATEDiscontinued

EPHEDRINE SULFATE 50MG/ML (50MG/ML) · SOLUTION · INTRAVENOUS

2024-06-10Labeling · Supplement 12 · standard — Letter ↗AP

2022-08-08Manufacturing (CMC) · Supplement 6 — Letter ↗TA

2017-07-03Manufacturing (CMC) · Supplement 1AP

2017-03-01Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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