Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050808
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/08/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050808s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050808s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/21/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050808Orig1s023ltr.pdf | |
| 07/15/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/2011 | SUPPL-15 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s015ltr.pdf |
| 03/18/2011 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050808Orig1s014.pdf | |
| 08/07/2010 | SUPPL-13 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf | |
| 12/30/2009 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s011ltr.pdf | |
| 07/23/2009 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s007ltr.pdf | |
| 02/27/2007 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/21/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf | |
| 03/18/2011 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf | |
| 08/07/2010 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf | |
| 12/30/2009 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf | |
| 07/23/2009 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf | |
| 07/23/2009 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf | |
| 05/08/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf |
SOLODYN
TABLET, EXTENDED RELEASE;ORAL; EQ 65MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 050808 | BAUSCH |
TABLET, EXTENDED RELEASE;ORAL; EQ 115MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 050808 | BAUSCH |
TABLET, EXTENDED RELEASE;ORAL; EQ 105MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 050808 | BAUSCH |
TABLET, EXTENDED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 050808 | BAUSCH |
TABLET, EXTENDED RELEASE;ORAL; EQ 55MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091424 | CHARTWELL RX |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |
| SOLODYN | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 050808 | BAUSCH |