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Gabapentin

Gabapentin Capsules

Approved
Approval ID

417231e9-129a-4a47-ab2e-cda97d096950

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2012

Manufacturers
FDA

STAT Rx USA LLC

DUNS: 786036330

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Gabapentin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42549-513
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2012
FDA Product Classification

INGREDIENTS (1)

GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB

Gabapentin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42549-512
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2012
FDA Product Classification

INGREDIENTS (1)

GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB

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Gabapentin - FDA Drug Approval Details