Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209903
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% 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
08/03/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

DICLOFENAC SODIUM

GEL;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 208077 AMNEAL PHARMS
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 209903 CIPLA
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 209484 HI TECH
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 204306 MYLAN
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 211253 PERRIGO UK FINCO
VOLTAREN DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription Yes AB 022122 GLAXOSMITHKLINE CONS

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