APPLICATION
ANDA075477
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-23
LATEST ACTION
2024-10-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2024-10-11Labeling · Supplement 8 · standardAP
2024-10-11Labeling · Supplement 10 · standardAP
2024-10-11Labeling · Supplement 9 · standardAP
2015-11-04Labeling · Supplement 6AP
2006-01-31Labeling · Supplement 2AP
2005-03-23OriginalAP
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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