← FDA DRUG APPROVALS

FDA NDA · NDA022544

GRALISE

gabapentin

Sponsor: ALMATICA

APPLICATION
NDA022544
TYPE
NDA
ORIGINAL APPROVAL
2011-01-28
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GRALISE · ReferencePrescription
GABAPENTIN 750MG · TABLET · ORAL
GRALISE · ReferencePrescription
GABAPENTIN 600MG · TABLET · ORAL
GRALISE · ReferencePrescription
GABAPENTIN 900MG · TABLET · ORAL
GRALISE · ReferencePrescription
GABAPENTIN 450MG · TABLET · ORAL
GRALISE · ReferencePrescription
GABAPENTIN 300MG · TABLET · ORAL

Approval history

2025-04-25Labeling · Supplement 31 · standard — Label ↗AP
2023-04-18Manufacturing (CMC) · Supplement 29 — Letter ↗AP
2021-09-16Manufacturing (CMC) · Supplement 27 — Letter ↗AP
2020-04-02Labeling · Supplement 26 · standard — Letter ↗AP
2017-03-06Labeling · Supplement 24 · standardAP
2017-01-09Manufacturing (CMC) · Supplement 23 · standardAP
2013-09-09Manufacturing (CMC) · Supplement 21 · standardAP
2013-07-31Manufacturing (CMC) · Supplement 19 · standardAP
2013-06-10Manufacturing (CMC) · Supplement 20 · standardAP
2013-04-09Manufacturing (CMC) · Supplement 17 · standardAP
2013-03-28Manufacturing (CMC) · Supplement 16 · standardAP
2013-03-27Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2013-03-25Manufacturing (CMC) · Supplement 14 · standardAP
2013-02-13Manufacturing (CMC) · Supplement 15 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 13 · standardAP
2012-11-30Manufacturing (CMC) · Supplement 10 · standardAP
2012-08-08Labeling · Supplement 8 · standard — Label ↗AP
2012-01-31Labeling · Supplement 6 · standard — Label ↗AP
2011-06-28Labeling · Supplement 2 · standard — Label ↗AP
2011-04-28REMS · Supplement 3 — Letter ↗AP
2011-01-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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