| Product NDC: | 0003-6335 |
| Proprietary Name: | DROXIA |
| Non Proprietary Name: | HYDROXYUREA |
| Active Ingredient(s): | 200 mg/1 & nbsp; HYDROXYUREA |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0003-6335 |
| Labeler Name: | E.R. Squibb & Sons, L.L.C. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA016295 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090601 |
| Package NDC: | 0003-6335-17 |
| Package Description: | 60 CAPSULE in 1 BOTTLE (0003-6335-17) |
| NDC Code | 0003-6335-17 |
| Proprietary Name | DROXIA |
| Package Description | 60 CAPSULE in 1 BOTTLE (0003-6335-17) |
| Product NDC | 0003-6335 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | HYDROXYUREA |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20090601 |
| Marketing Category Name | NDA |
| Labeler Name | E.R. Squibb & Sons, L.L.C. |
| Substance Name | HYDROXYUREA |
| Strength Number | 200 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Antimetabolite [EPC],Urea [Chemical/Ingredient] |