Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200936
Company: TOLMAR
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 208301 GLENMARK PHARMS LTD
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 210893 PERRIGO UK FINCO
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 206298 TARO
DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription No AB 200936 TOLMAR
SOLARAZE DICLOFENAC SODIUM 3% GEL;TOPICAL Prescription Yes AB 021005 FOUGERA PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English