Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204132
Company: LUPIN LTD
Company: LUPIN LTD
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 |
---|---|---|---|---|---|---|---|
08/20/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204132Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/24/2021 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/14/2020 | SUPPL-2 | Labeling-Package Insert |
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 |