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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074901
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription AP 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
07/18/1997 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
07/26/2018 SUPPL-20 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/23/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/26/2001 SUPPL-3 Labeling

Label is not available on this site.

04/03/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

ATRACURIUM BESYLATE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 206011 EUGIA PHARMA
ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 074901 HIKMA
ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 090761 HOSPIRA INC
ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 091489 MEITHEAL
ATRACURIUM BESYLATE PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 206010 EUGIA PHARMA
ATRACURIUM BESYLATE PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 074900 HIKMA
ATRACURIUM BESYLATE PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 090782 HOSPIRA INC
ATRACURIUM BESYLATE PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 091488 MEITHEAL
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