Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201922
Company: JOURNEY
Company: JOURNEY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XIMINO | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
XIMINO | MINOCYCLINE HYDROCHLORIDE | EQ 67.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
XIMINO | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
XIMINO | MINOCYCLINE HYDROCHLORIDE | EQ 112.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
XIMINO | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | CAPSULE, 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 |
---|---|---|---|---|---|---|---|
07/11/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201922s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201922Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922_ximino_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/13/2015 | SUPPL-2 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201922s002lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/13/2015 | SUPPL-2 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201922s002lbl.pdf |
07/11/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201922s000lbl.pdf |