Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Direct_Rx
ORAL
PRESCRIPTION DRUG
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
Abbreviated New Drug Application
Direct_Rx ---------- Revised: 5/2023 Document Id: fb591a28-d72a-377e-e053-6394a90a2903 34391-3 Set id: 907853a0-9979-62e7-e053-2995a90a5aca Version: 3 Effective Time: 20230510 Direct_Rx Baca dokumen lengkap
GABAPENTIN- GABAPENTIN CAPSULE DIRECT_RX ---------- GABAPENTIN 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 GABAPENTIN gabapentin capsule PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:61919-640(NDC:49483- 606) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 300 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) GELATIN (UNII: 2G86QN327L) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) PRODUCT CHARACTERISTICS COLOR yellow SCORE no score SHAPE CAPSULE SIZE 19mm FLAVOR IMPRINT CODE 104 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:61919-640- 90 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2019 2 NDC:61919-640- 82 180 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2019 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA090007 08/19/2019 LABELER - Direct_Rx (079254320) REGISTRANT - Direct_Rx (079254320) Direct_Rx ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Direct_Rx 079254320 repack(61919-640) Revised: 5/2023 Baca dokumen lengkap