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 ID | 61269-404_48698c6a-61d3-4417-8758-3263fba53352 |
NDC | 61269-404 |
Product Type | Human Prescription Drug |
Proprietary Name | DROXIA |
Generic Name | Hydroxyurea |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2009-06-01 |
Marketing Category | NDA / |
Application Number | NDA016295 |
Labeler Name | H2-Pharma LLC |
Substance Name | HYDROXYUREA |
Active Ingredient Strength | 400 mg/1 |
Pharm Classes | Antimetabolite [EPC], Urea [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2015-07-16 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
0003-6335 | DROXIA | HYDROXYUREA |
0003-6336 | DROXIA | HYDROXYUREA |
0003-6337 | DROXIA | HYDROXYUREA |
0003-0830 | HYDREA | HYDROXYUREA |
0093-0882 | HYDROXYUREA | Hydroxyurea |
0555-0882 | HYDROXYUREA | Hydroxyurea |
0904-6939 | Hydroxyurea | Hydroxyurea |
10135-702 | Hydroxyurea | Hydroxyurea |
24535-0831 | Hydroxyurea | Hydroxyurea |
42291-321 | HYDROXYUREA | Hydroxyurea |
49884-724 | Hydroxyurea | Hydroxyurea |
55154-3554 | Hydroxyurea | Hydroxyurea |
55154-7143 | Hydroxyurea | Hydroxyurea |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DROXIA 75318230 2222043 Live/Registered |
BRISTOL-MYERS SQUIBB COMPANY 1997-07-02 |