NDC 61269-403

DROXIA

Hydroxyurea

DROXIA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H2-pharma Llc. The primary component is Hydroxyurea.

Product ID61269-403_48698c6a-61d3-4417-8758-3263fba53352
NDC61269-403
Product TypeHuman Prescription Drug
Proprietary NameDROXIA
Generic NameHydroxyurea
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA /
Application NumberNDA016295
Labeler NameH2-Pharma LLC
Substance NameHYDROXYUREA
Active Ingredient Strength300 mg/1
Pharm ClassesAntimetabolite [EPC], Urea [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61269-403-60

60 CAPSULE in 1 BOTTLE (61269-403-60)
Marketing Start Date2015-07-16
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "DROXIA" or generic name "Hydroxyurea"

NDCBrand NameGeneric Name
0003-6335DROXIAHYDROXYUREA
0003-6336DROXIAHYDROXYUREA
0003-6337DROXIAHYDROXYUREA
0003-0830HYDREAHYDROXYUREA
0093-0882HYDROXYUREAHydroxyurea
0555-0882HYDROXYUREAHydroxyurea
0904-6939HydroxyureaHydroxyurea
10135-702HydroxyureaHydroxyurea
24535-0831HydroxyureaHydroxyurea
42291-321HYDROXYUREAHydroxyurea
49884-724HydroxyureaHydroxyurea
55154-3554HydroxyureaHydroxyurea
55154-7143HydroxyureaHydroxyurea

Trademark Results [DROXIA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DROXIA
DROXIA
75318230 2222043 Live/Registered
BRISTOL-MYERS SQUIBB COMPANY
1997-07-02

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