Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205833
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION;IV (INFUSION) Prescription AP 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
05/05/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

SOLUTION;IV (INFUSION); 400MG/250ML (1.6MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION;IV (INFUSION) Prescription Yes AP 021277 BAYER HLTHCARE
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205833 MYLAN LABS LTD

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