Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200936
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/28/2013 | ORIG-1 | Approval | Not Applicable |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200936Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200936Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/200936Orig1s001.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/28/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200936Orig1s000lbl.pdf |
DICLOFENAC SODIUM
GEL;TOPICAL; 3%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | No | AB | 206493 | ACTAVIS MID ATLANTIC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | No | AB | 212351 | ALEMBIC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | No | AB | 200936 | AMNEAL |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | No | AB | 208301 | GLENMARK PHARMS LTD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | No | AB | 210893 | PADAGIS ISRAEL |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 3% | GEL;TOPICAL | Prescription | No | AB | 206298 | TARO |