Orange Book product

HYDROXOCOBALAMIN 1MG/ML

Orange Book ANDA 085998 · ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name HYDROXOCOBALAMIN
Active ingredients HYDROXOCOBALAMIN
Strength 1MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA085998
Applicant holder ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 1, 1982

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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