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
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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