Orange Book product

ROCURONIUM BROMIDE 50MG/5ML (10MG/ML)

Orange Book ANDA 204679 · WEST WARD PHARMACEUTICAL CORP · Prescription

Key facts

Proprietary name ROCURONIUM BROMIDE
Active ingredients ROCURONIUM BROMIDE
Strength 50MG/5ML (10MG/ML)
Dosage form INJECTABLE
Route INJECTION
Application ANDA204679
Applicant holder WEST WARD PHARMACEUTICAL CORP
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 28, 2017

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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