Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202584
Company: AILEX PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG TABLET, CHEWABLE, TABLET, CAPSULE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/2018 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202584Orig1s000ltr.pdf

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