FDA NDA · NDA005939

BAL

Sponsor: PROVEPHARM SAS

APPLICATION

NDA005939

TYPE

NDA

ORIGINAL APPROVAL

1946-05-06

LATEST ACTION

2026-03-18

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

BAL · ReferencePrescription

DIMERCAPROL 10% · INJECTABLE · INJECTION

2026-03-18Labeling · Supplement 18 · standard — Letter ↗AP

2026-03-04Labeling · Supplement 17 · standard — Label ↗AP

2022-08-08Manufacturing (CMC) · Supplement 12 — Letter ↗TA

2007-04-18Labeling · Supplement 7 · standard — Letter ↗AP

2006-09-26Manufacturing (CMC) · Supplement 6AP

1988-12-27Manufacturing (CMC) · Supplement 3AP

1977-07-29Labeling · Supplement 2AP

1946-05-06UNKNOWN · Original · unknownAP

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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