Orange Book product

MEPROBAMATE 400MG

Orange Book ANDA 090122 · ALEMBIC PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name MEPROBAMATE
Active ingredients MEPROBAMATE
Strength 400MG
Dosage form TABLET
Route ORAL
Application ANDA090122
Applicant holder ALEMBIC PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Feb 18, 2009

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)

Browse all Orange Book products