APPLICATION
ANDA078974
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-18
LATEST ACTION
2024-06-20
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 250MG/5ML · SOLUTION · ORAL
Approval history
2024-06-20Labeling · Supplement 7 · standardAP
2024-06-20Labeling · Supplement 5 · standardAP
2024-06-20Labeling · Supplement 13 · standardAP
2015-05-08Labeling · Supplement 3 · standardAP
2015-05-08Labeling · Supplement 4 · standardAP
2015-01-22Manufacturing (CMC) · Supplement 2AP
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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