Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050697
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIAXIN XL | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | None | No | No |
| BIAXIN XL | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/1993 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/19/2004 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf |
| 05/24/2002 | SUPPL-2 | Efficacy-Accelerated Approval |
Label is not available on this site. |