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FDA Drug information

Gabapentin

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230926

Version

7

Spl Product Data Elements

Gabapentin Gabapentin GABAPENTIN GABAPENTIN COPOVIDONE K25-31 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE MANNITOL POLOXAMER 407 POVIDONE TALC WHITE TO OFF-WHITE OVAL ZE72 Gabapentin Gabapentin GABAPENTIN GABAPENTIN COPOVIDONE K25-31 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE MANNITOL POLOXAMER 407 POVIDONE TALC WHITE TO OFF-WHITE OVAL ZE71

Application Number

ANDA078926

Brand Name

Gabapentin

Generic Name

Gabapentin

Product Ndc

65841-706

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-705-01 in bottle of 100 tablets Gabapentin Tablets USP, 600 mg R x only 100 tablets NDC 65841-706-01 in bottle of 100 tablets Gabapentin Tablets USP, 800 mg R x only 100 tablets Gabapentin tablets Gabapentin tablets

Spl Medguide

Manufactured by: Cadila Heathcare Ltd. India

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