Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211786
Company: PERRIGO UK FINCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;VAGINAL 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
07/02/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

METRONIDAZOLE

GEL;VAGINAL; 0.75%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METROGEL-VAGINAL METRONIDAZOLE 0.75% GEL;VAGINAL Prescription Yes AB 020208 BAUSCH
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;VAGINAL Prescription No AB 211786 PERRIGO UK FINCO
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;VAGINAL Prescription No AB 077264 TOLMAR

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