APPLICATION
ANDA211314
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-16
LATEST ACTION
2025-11-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
Approval history
2025-11-24Labeling · Supplement 18 · standardAP
2025-07-21Labeling · Supplement 9 · standardAP
2025-07-21Labeling · Supplement 17 · standardAP
2025-02-04Labeling · Supplement 3 · standardAP
2025-02-04Labeling · Supplement 4 · standardAP
2018-10-16UNKNOWN · 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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