Orange Book product

LITHIUM CARBONATE 450MG

Orange Book ANDA 076490 · HIKMA INTERNATIONAL PHARMACEUTICALS LLC · Discontinued

Key facts

Proprietary name LITHIUM CARBONATE
Active ingredients LITHIUM CARBONATE
Strength 450MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA076490
Applicant holder HIKMA INTERNATIONAL PHARMACEUTICALS LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 17, 2003

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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