Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075020
Company: BARR LABS INC
Company: BARR LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75020_Hydroxyurea.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/13/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |