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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071308
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 5MG/ML INJECTABLE;INJECTION 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
07/17/1987 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
01/17/2023 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
09/02/2021 SUPPL-8 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/071308s008lbl.pdf
02/05/2021 SUPPL-7 Labeling, Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
12/08/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
08/25/1994 SUPPL-4 Labeling

Label is not available on this site.
06/16/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/18/1991 SUPPL-2 Labeling

Label is not available on this site.
01/21/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/02/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/071308s008lbl.pdf
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