Orange Book product

BROMOCRIPTINE MESYLATE EQ 2.5MG BASE

Orange Book ANDA 077646 · PADAGIS US LLC · Prescription

Key facts

Proprietary name BROMOCRIPTINE MESYLATE
Active ingredients BROMOCRIPTINE MESYLATE
Strength EQ 2.5MG BASE
Dosage form TABLET
Route ORAL
Application ANDA077646
Applicant holder PADAGIS US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Oct 1, 2008

At a glance

  • 1–9 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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