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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

20230510

Version

3

Spl Product Data Elements

GABAPENTIN GABAPENTIN FERRIC OXIDE YELLOW TALC GELATIN GABAPENTIN GABAPENTIN STARCH, CORN TITANIUM DIOXIDE LACTOSE MONOHYDRATE ANHYDROUS LACTOSE PROPYLENE GLYCOL SHELLAC 104

Application Number

ANDA090007

Brand Name

GABAPENTIN

Generic Name

GABAPENTIN

Product Ndc

61919-640

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

640-90

How Supplied

100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

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