Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090422
Company: SANDOZ
Company: SANDOZ
| 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 | Prescription | AB | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | Yes |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE; ORAL | None (Tentative Approval) | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | Tablet, Extended Release; Oral | None (Tentative Approval) | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | Tablet, Extended Release; Oral | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 08/13/2009 | 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 |
|---|---|---|---|---|---|
| 08/26/2015 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/02/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2012 | SUPPL-6 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 01/21/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
MINOCYCLINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; EQ 45MG 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 45MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091424 | CHARTWELL RX |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090422 | SANDOZ |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |
TABLET, EXTENDED RELEASE;ORAL; EQ 90MG 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 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091424 | CHARTWELL RX |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090422 | SANDOZ |
TABLET, EXTENDED RELEASE;ORAL; EQ 135MG 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 135MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204453 | ALKEM LABS LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202261 | AUROBINDO PHARMA LTD |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091424 | CHARTWELL RX |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090422 | SANDOZ |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204394 | SIDMAK LABS INDIA |