Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206655
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
01/28/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DICLOFENAC SODIUM
SOLUTION;TOPICAL; 1.5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 206116 | AMNEAL PHARMS |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 206655 | EPIC PHARMA LLC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 204132 | LUPIN LTD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 205878 | NOVEL LABS INC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 203818 | TARO |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 202852 | WATSON LABS INC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION;TOPICAL | Prescription | No | AT | 206411 | ZYDUS LIFESCIENCES |