Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075143
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | AB | No | No |
| HYDROXYUREA | HYDROXYUREA | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/16/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75143ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75143_Hydroxyurea.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/27/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/14/2011 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/15/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/28/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/27/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROXYUREA
CAPSULE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | Yes | AB | 016295 | CHEPLAPHARM |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 075143 | BARR |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 075340 | ENDO OPERATIONS |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 213438 | LEADING |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 218021 | QILU |