Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
NuCare Pharmaceuticals,Inc.
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) NDC 68071-5017-1 BOTTLES OF 100
Abbreviated New Drug Application
NuCare Pharmaceuticals,Inc. ---------- Revised: 2/2021 Document Id: bbb33d86-a7ae-a3a4-e053-2a95a90a18df 34391-3 Set id: 8f785189-bf66-36cc-e053-2a95a90a7cbc Version: 2 Effective Time: 20210219 NuCare Pharmaceuticals,Inc. Đọc toàn bộ tài liệu
GABAPENTIN- GABAPENTIN CAPSULE NUCARE PHARMACEUTICALS,INC. ---------- 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) NDC 68071-5017-1 BOTTLES OF 100 100 MG GABAPENTIN CAPSULE PACKAGE LABELS GABAPENTIN gabapentin capsule PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:68071-5017(NDC:49483- 605) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 100 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) PRODUCT CHARACTERISTICS COLOR white SCORE no score SHAPE CAPSULE SIZE 16mm FLAVOR IMPRINT CODE 103 NuCare Pharmaceuticals,Inc. CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:68071- 5017-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/06/2019 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA090007 12/30/2015 LABELER - NuCare Pharmaceuticals,Inc. (010632300) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5017) Revised: 2/2021 Đọc toàn bộ tài liệu