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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206477
Company: CHARTWELL MOLECULAR

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG/5ML 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
06/24/2016 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/2023 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
02/05/2021 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

DIAZEPAM

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION;ORAL Prescription No AA 206477 CHARTWELL MOLECULAR
DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION;ORAL Prescription No AA 070928 HIKMA
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