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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216795
Company: ENCUBE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 1.3% 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
03/18/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216795Orig1s000TAltr.pdf

METRONIDAZOLE

GEL;VAGINAL; 1.3%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METRONIDAZOLE METRONIDAZOLE 1.3% GEL;VAGINAL Prescription No AB 216795 ENCUBE
NUVESSA METRONIDAZOLE 1.3% GEL;VAGINAL Prescription Yes AB 205223 CHEMO RESEARCH SL
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