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FDA NDA · NDA014134

PROTOPAM CHLORIDE

pralidoxime chloride

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA014134
TYPE
NDA
ORIGINAL APPROVAL
1964-03-11
LATEST ACTION
2014-01-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PROTOPAM CHLORIDE · ReferencePrescription
PRALIDOXIME CHLORIDE 1GM/VIAL · INJECTABLE · INJECTION

Approval history

2014-01-15Manufacturing (CMC) · Supplement 35 · priorityAP
2013-05-03Manufacturing (CMC) · Supplement 34 · priorityAP
2012-11-30Manufacturing (CMC) · Supplement 32 · priorityAP
2010-09-08Labeling · Supplement 22 · standard — Label ↗AP
2002-12-04Manufacturing (CMC) · Supplement 25 · priorityAP
2002-09-27Labeling · Supplement 24 · standard — Letter ↗AP
2002-05-06Manufacturing (CMC) · Supplement 23 · priorityAP
1995-12-11Labeling · Supplement 21 · standardAP
1993-04-26Manufacturing (CMC) · Supplement 19 · priorityAP
1992-04-28Manufacturing (CMC) · Supplement 20 · priorityAP
1992-04-28Manufacturing (CMC) · Supplement 17 · priorityAP
1991-07-15Manufacturing (CMC) · Supplement 18 · priorityAP
1986-05-21Manufacturing (CMC) · Supplement 16 · priorityAP
1985-08-23Manufacturing (CMC) · Supplement 15 · priorityAP
1985-08-21Manufacturing (CMC) · Supplement 14 · priorityAP
1985-07-02Labeling · Supplement 13AP
1985-05-20Manufacturing (CMC) · Supplement 12 · priorityAP
1981-06-17Manufacturing (CMC) · Supplement 10 · priorityAP
1981-02-13Manufacturing (CMC) · Supplement 9 · priorityAP
1980-09-11Manufacturing (CMC) · Supplement 8 · priorityAP
1980-04-15Manufacturing (CMC) · Supplement 7 · priorityAP
1978-03-28Manufacturing (CMC) · Supplement 6 · priorityAP
1974-11-11Manufacturing (CMC) · Supplement 5 · priorityAP
1964-03-11Type 1 - New Molecular Entity · Original · priorityAP
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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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