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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075875
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Discontinued None 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
12/21/2000 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75875ltr.pdf
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