Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203443
Company: RISING PHARMA
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG 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 |
---|---|---|---|---|---|---|---|
08/21/2019 | ORIG-2 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203443Orig1s000ltr.pdf | ||
08/22/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203443Orig1s000ltr.pdf |