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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072058
Company: ELKINS SINN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PANCURONIUM BROMIDE PANCURONIUM BROMIDE 1MG/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
03/23/1988 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
09/10/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-12 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/07/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/19/1993 SUPPL-7 Labeling

Label is not available on this site.

10/22/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/07/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/08/1989 SUPPL-2 Labeling

Label is not available on this site.

06/17/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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