Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207714
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
05/06/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207714Orig1s000TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207714Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/21/2024 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
DICLOFENAC SODIUM
SOLUTION;TOPICAL; 2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | Prescription | No | AB | 212506 | ALEMBIC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | Prescription | No | AB | 208198 | AMNEAL |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | Prescription | No | AB | 207714 | APOTEX |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | Prescription | No | AB | 213040 | AUROLIFE PHARMA LLC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | Prescription | No | AB | 208021 | LUPIN PHARMS |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION;TOPICAL | Prescription | No | AB | 208098 | TARO |