APPLICATION
ANDA090158
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-14
LATEST ACTION
2023-03-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2023-03-28Labeling · Supplement 11 · standardAP
2020-09-08Labeling · Supplement 8 · standardAP
2020-09-08Labeling · Supplement 6 · standardAP
2020-09-08Labeling · Supplement 10 · standardAP
2020-09-08Labeling · Supplement 9 · standardAP
2020-09-08Labeling · Supplement 5 · standardAP
2015-05-04Labeling · Supplement 4 · standardAP
2015-05-04Labeling · Supplement 2 · standardAP
2011-02-14OriginalAP
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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