Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209863
Company: ANTARES PHARMA INC
Company: ANTARES PHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | 50MG/0.5ML (50MG/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | 75MG/0.5ML (75MG/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | 100MG/0.5ML (100MG/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/28/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209863Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209863Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/19/2019 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209863s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209863Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/19/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209863s002lbl.pdf | |
09/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf |