Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203818
Company: TARO
Company: TARO
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 | 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 |
---|---|---|---|---|---|---|---|
11/26/2014 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/30/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/02/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
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 |