Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065485
Company: BARR LABS INC
Company: BARR 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 |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG 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 |
|---|---|---|---|---|---|---|---|
| 03/17/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/28/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-8 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/065485Orig1s005,065485Orig1s008TAltr.pdf |
| 11/26/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2017 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/065485Orig1s005,065485Orig1s008TAltr.pdf |
| 05/18/2012 | SUPPL-4 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065485Orig1s004ltr.pdf |