Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081309
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE MEPERIDINE HYDROCHLORIDE 10MG/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
08/30/1993 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
10/11/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/27/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/19/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/25/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/18/1994 SUPPL-3 Labeling

Label is not available on this site.

04/18/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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