Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090024
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/03/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090024s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |