APPLICATION
ANDA202024
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-23
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 250MG/5ML · SOLUTION · ORAL
Approval history
2025-09-16Labeling · Supplement 19 · standardAP
2025-09-16Labeling · Supplement 21 · standardAP
2024-05-29Labeling · Supplement 4 · standardAP
2024-05-29Labeling · Supplement 7 · standardAP
2024-05-29Labeling · Supplement 10 · standardAP
2024-05-29Labeling · Supplement 5 · standardAP
2024-05-29Labeling · Supplement 3 · standardAP
2024-05-29Labeling · Supplement 11 · standardAP
2014-11-08Labeling · Supplement 2 · standardAP
2014-11-08Labeling · Supplement 1 · standardAP
2012-03-23Not Applicable · OriginalAP
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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