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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088744
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG/5ML SYRUP;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
01/30/1985 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
12/22/2025 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
10/31/2024 SUPPL-34 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/13/2024 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
12/14/2023 SUPPL-31 Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
10/08/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
10/04/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-27 REMS - PROPOSAL - D-N-A

Label is not available on this site.
04/28/2017 SUPPL-26 Labeling-Package Insert

Label is not available on this site.
03/30/2012 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
05/18/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
04/28/2009 SUPPL-21 Labeling

Label is not available on this site.
09/26/2005 SUPPL-19 Labeling

Label is not available on this site.
06/24/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
06/24/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
11/14/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
11/14/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
08/28/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
08/07/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
01/10/1997 SUPPL-11 Labeling

Label is not available on this site.
01/10/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
01/10/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
04/05/1990 SUPPL-4 Labeling

Label is not available on this site.
09/19/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/19/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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