Orange Book product

MORPHINE SULFATE 60MG

Orange Book ANDA 079040 · ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Prescription

Key facts

Proprietary name MORPHINE SULFATE
Active ingredients MORPHINE SULFATE
Strength 60MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA079040
Applicant holder ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 16, 2013

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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