APPLICATION
ANDA060101
TYPE
ANDA
ORIGINAL APPROVAL
1948-04-26
LATEST ACTION
2025-08-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PENICILLIN G PROCAINEPrescription
PENICILLIN G PROCAINE 300,000 UNITS/ML · INJECTABLE · INJECTION
PENICILLIN G PROCAINEPrescription
PENICILLIN G PROCAINE 600,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2025-08-26Labeling · Supplement 49 · standardAP
2025-08-26Labeling · Supplement 47 · standardAP
2025-08-26Labeling · Supplement 46 · standardAP
2024-06-07Labeling · Supplement 43 · standardAP
2024-06-07Labeling · Supplement 41 · standardAP
2024-06-07Labeling · Supplement 42 · standardAP
2024-06-07Labeling · Supplement 40 · standardAP
2019-01-24Labeling · Supplement 39 · standardAP
2018-07-02Labeling · Supplement 35 · standardAP
2018-07-02Labeling · Supplement 31AP
2018-07-02Labeling · Supplement 38 · standardAP
2015-12-16Labeling · Supplement 36 · standardAP
2015-12-16Labeling · Supplement 34AP
2004-04-23Labeling · Supplement 20AP
2001-04-12Manufacturing (CMC) · Supplement 19AP
1998-04-20Manufacturing (CMC) · Supplement 18AP
1995-06-28Labeling · Supplement 13AP
1993-08-02Labeling · Supplement 16AP
1993-07-30Manufacturing (CMC) · Supplement 15AP
1991-01-14Manufacturing (CMC) · Supplement 12AP
1989-05-31Labeling · Supplement 14AP
1948-04-26OriginalAP
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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