Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206298
Company: TARO
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
04/28/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206298Orig1s000ltr.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

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