Orange Book product

PROPRANOLOL HYDROCHLORIDE 1MG/ML

Orange Book ANDA 070135 · SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW · Discontinued

Key facts

Proprietary name PROPRANOLOL HYDROCHLORIDE
Active ingredients PROPRANOLOL HYDROCHLORIDE
Strength 1MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA070135
Applicant holder SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 15, 1986

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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