Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202090
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM OXYBATE SODIUM OXYBATE 500MG/ML SOLUTION;ORAL Prescription AA 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
01/17/2017 ORIG-1 Approval Not Applicable Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202090Orig1s000ltredt.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf

SODIUM OXYBATE

SOLUTION;ORAL; 500MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM OXYBATE SODIUM OXYBATE 500MG/ML SOLUTION;ORAL Prescription No AA 202090 WEST-WARD PHARMS INT
XYREM SODIUM OXYBATE 500MG/ML SOLUTION;ORAL Prescription Yes AA 021196 JAZZ PHARMS

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