Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207238
Company: ACTAVIS LABS UT INC
Company: ACTAVIS LABS UT INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
11/02/2017 | ORIG-1 | Tentative Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207238ORig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207238Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2017 | ORIG-1 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207238ORig1s000lbl.pdf |