Orange Book product

CARBIDOPA AND LEVODOPA 50MG;200MG

Orange Book ANDA 076521 · IMPAX LABORATORIES INC · Prescription

Key facts

Proprietary name CARBIDOPA AND LEVODOPA
Active ingredients CARBIDOPA, LEVODOPA
Strength 50MG;200MG
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA076521
Applicant holder IMPAX LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 14, 2004

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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