Orange Book product

LEVOBUNOLOL HYDROCHLORIDE 0.5%

Orange Book ANDA 074326 · BAUSCH AND LOMB INC · Prescription

Key facts

Proprietary name LEVOBUNOLOL HYDROCHLORIDE
Active ingredients LEVOBUNOLOL HYDROCHLORIDE
Strength 0.5%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA074326
Applicant holder BAUSCH AND LOMB INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 4, 1994

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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