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Medicines · US (FDA)
Antiepileptics

FDA 2014

Gabapentinoids

Pregabalin

Approved 21 Feb 2014OralCapsule

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: PREGABALIN 300MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

PREGABALIN 25MG · CapsuleANDA091219-001 · Discontinued
PREGABALIN 50MG · CapsuleANDA091219-002 · Discontinued
PREGABALIN 300MG · CapsuleANDA091221-008 · Tentative approval
PREGABALIN 200MG · CapsuleANDA091221-006 · Tentative approval
PREGABALIN 100MG · CapsuleANDA091221-004 · Tentative approval
PREGABALIN 50MG · CapsuleANDA091221-002 · Tentative approval
PREGABALIN 225MG · CapsuleANDA091221-007 · Tentative approval
PREGABALIN 150MG · CapsuleANDA091221-005 · Tentative approval
PREGABALIN 75MG · CapsuleANDA091221-003 · Tentative approval
PREGABALIN 25MG · CapsuleANDA091221-001 · Tentative approval
PREGABALIN 300MG · CapsuleThis page
PREGABALIN 200MG · CapsuleANDA203022-006 · Tentative approval

More in antiepileptics

BrivaracetamSolution

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

PREGABALIN 100MG · CapsuleANDA203022-004 · Tentative approval

PREGABALIN 50MG · CapsuleANDA203022-002 · Tentative approval

PREGABALIN 225MG · CapsuleANDA203022-007 · Tentative approval

PREGABALIN 150MG · CapsuleANDA203022-005 · Tentative approval

PREGABALIN 75MG · CapsuleANDA203022-003 · Tentative approval

PREGABALIN 25MG · CapsuleANDA203022-001 · Tentative approval

PREGABALIN 225MG · CapsuleANDA203459-007 · Prescription

PREGABALIN 150MG · CapsuleANDA203459-005 · Prescription

PREGABALIN 75MG · CapsuleANDA203459-003 · Prescription

PREGABALIN 25MG · CapsuleANDA203459-001 · Prescription

PREGABALIN 300MG · CapsuleANDA203459-008 · Prescription

PREGABALIN 200MG · CapsuleANDA203459-006 · Prescription

PREGABALIN 100MG · CapsuleANDA203459-004 · Prescription

PREGABALIN 50MG · CapsuleANDA203459-002 · Prescription

PREGABALIN 75MG · CapsuleANDA206912-003 · Prescription

PREGABALIN 25MG · CapsuleANDA206912-001 · Prescription

PREGABALIN 300MG · CapsuleANDA206912-008 · Prescription

PREGABALIN 200MG · CapsuleANDA206912-006 · Prescription

PREGABALIN 100MG · CapsuleANDA206912-004 · Prescription

PREGABALIN 50MG · CapsuleANDA206912-002 · Prescription

PREGABALIN 225MG · CapsuleANDA206912-007 · Prescription

PREGABALIN 150MG · CapsuleANDA206912-005 · Prescription

PREGABALIN 225MG · CapsuleANDA206942-007 · Prescription

PREGABALIN 150MG · CapsuleANDA206942-005 · Prescription

PREGABALIN 75MG · CapsuleANDA206942-003 · Prescription

PREGABALIN 25MG · CapsuleANDA206942-001 · Prescription

PREGABALIN 300MG · CapsuleANDA206942-008 · Prescription

PREGABALIN 200MG · CapsuleANDA206942-006 · Prescription

PREGABALIN 100MG · CapsuleANDA206942-004 · Prescription

PREGABALIN 50MG · CapsuleANDA206942-002 · Prescription

PREGABALIN 225MG · CapsuleANDA212280-007 · Discontinued

PREGABALIN 150MG · CapsuleANDA212280-005 · Discontinued

PREGABALIN 75MG · CapsuleANDA212280-003 · Discontinued

PREGABALIN 25MG · CapsuleANDA212280-001 · Discontinued

PREGABALIN 300MG · CapsuleANDA212280-008 · Discontinued

PREGABALIN 200MG · CapsuleANDA212280-006 · Discontinued

PREGABALIN 100MG · CapsuleANDA212280-004 · Discontinued

PREGABALIN 50MG · CapsuleANDA212280-002 · Discontinued

PREGABALIN 330MG · Tablet, extended releaseANDA215577-003 · Discontinued

PREGABALIN 82.5MG · Tablet, extended releaseANDA215577-001 · Discontinued

PREGABALIN 165MG · Tablet, extended releaseANDA215577-002 · Discontinued

PREGABALIN 20MG/ML · SolutionANDA201989-001 · Tentative approval

PREGABALIN 20MG/ML · SolutionANDA202269-001 · Tentative approval

PREGABALIN 300MG · CapsuleANDA209743-008 · Prescription

PREGABALIN 200MG · CapsuleANDA209743-006 · Prescription

PREGABALIN 100MG · CapsuleANDA209743-004 · Prescription

PREGABALIN 50MG · CapsuleANDA209743-002 · Prescription

PREGABALIN 225MG · CapsuleANDA209743-007 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA203022.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Pregabalin
Drug class: Gabapentinoids
Group: Antiepileptics
Route: Oral
Dosage form: Capsule
Applicant: Apotex Inc
Status: Tentative approval
FDA approval: 21 Feb 2014
Application: ANDA203022-008
RxCUI: 187832

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