Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204433
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG/ML CONCENTRATE;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
04/14/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

DIAZEPAM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 5MG/ML CONCENTRATE;ORAL Prescription No AA 204433 LANNETT CO INC
DIAZEPAM INTENSOL DIAZEPAM 5MG/ML CONCENTRATE;ORAL Prescription No AA 071415 WEST-WARD PHARMS INT

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