APPLICATION
ANDA075350
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-12
LATEST ACTION
2026-01-29
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
2026-01-29Labeling · Supplement 80 · standardAP
2025-01-07Labeling · Supplement 77 · standardAP
2025-01-07Labeling · Supplement 72 · standardAP
2021-04-26Labeling · Supplement 67 · standardAP
2020-07-21Labeling · Supplement 66 · standardAP
2020-07-21Labeling · Supplement 60 · standardAP
2016-01-13Labeling · Supplement 57 · standardAP
2016-01-13Labeling · Supplement 49 · standardAP
2015-03-16Labeling · Supplement 54 · standardAP
2012-08-28Manufacturing (CMC) · Supplement 32AP
2012-04-11Labeling · Supplement 35AP
2011-06-24Labeling · Supplement 29AP
2011-06-24Labeling · Supplement 28AP
2010-05-13Labeling · Supplement 22AP
2006-12-05Labeling · Supplement 14AP
2005-12-23Labeling · Supplement 9AP
2005-04-08Labeling · Supplement 4AP
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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