Orange Book product

ERGOTAMINE TARTRATE AND CAFFEINE 100MG;1MG

Orange Book ANDA 040590 · MIKART LLC · Prescription

Key facts

Proprietary name ERGOTAMINE TARTRATE AND CAFFEINE
Active ingredients CAFFEINE, ERGOTAMINE TARTRATE
Strength 100MG;1MG
Dosage form TABLET
Route ORAL
Application ANDA040590
Applicant holder MIKART LLC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Sep 16, 2005

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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