Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091118
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| 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 55MG BASE | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG 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 90MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG 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 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 |
|---|---|---|---|---|---|---|---|
| 12/03/2019 | ORIG-3 | Tentative Approval |
Label is not available on this site. |
||||
| 12/03/2019 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 09/25/2014 | ORIG-1 | Approval |
Label is not available on this site. |