Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081002
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE MEPERIDINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION 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
07/30/1993 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.

09/23/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/02/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/31/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/05/1995 SUPPL-5 Labeling

Label is not available on this site.

09/05/1995 SUPPL-4 Labeling

Label is not available on this site.

08/29/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/10/1994 SUPPL-2 Labeling

Label is not available on this site.

09/29/1994 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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