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FDA NDA · NDA050638

PENICILLIN G POTASSIUM

penicillin g

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA050638
TYPE
NDA
ORIGINAL APPROVAL
1990-06-25
LATEST ACTION
2023-11-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER · ReferencePrescription
PENICILLIN G POTASSIUM 60,000 UNITS/ML · INJECTABLE · INJECTION
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER · ReferencePrescription
PENICILLIN G POTASSIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER · ReferencePrescription
PENICILLIN G POTASSIUM 40,000 UNITS/ML · INJECTABLE · INJECTION

Approval history

2023-11-02Labeling · Supplement 21 · standard — Label ↗AP
2017-11-27Labeling · Supplement 20 · standard — Label ↗AP
2016-07-18Labeling · Supplement 19 · standard — Label ↗AP
2014-03-19Manufacturing (CMC) · Supplement 18 · standardAP
2012-04-16Labeling · Supplement 16 · standard — Letter ↗AP
2008-03-01Labeling · Supplement 12 · standard — Label ↗AP
2005-02-04Labeling · Supplement 11 · standard — Letter ↗AP
2004-06-10Labeling · Supplement 10 · standard — Letter ↗AP
2002-08-23Labeling · Supplement 7 · standard — Letter ↗AP
2000-11-07Manufacturing (CMC) · Supplement 8 · standardAP
1999-07-20Labeling · Supplement 6 · standardAP
1994-10-31Manufacturing (CMC) · Supplement 4 · standardAP
1992-11-03Manufacturing (CMC) · Supplement 1 · standardAP
1991-11-19Labeling · Supplement 2AP
1990-06-25Type 3 - New Dosage Form · Original · standardAP
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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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