APPLICATION
ANDA211330
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-03
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 250MG/5ML · SOLUTION · ORAL
Approval history
2025-02-18Manufacturing (CMC) · Supplement 6 · unknownAP
2021-06-25Labeling · Supplement 1 · standardAP
2021-06-25Labeling · Supplement 2 · standardAP
2019-12-03UNKNOWN · Original · standardAP
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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