Orange Book product

CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE

Orange Book ANDA 216957 · GLENMARK PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name CLINDAMYCIN HYDROCHLORIDE
Active ingredients CLINDAMYCIN HYDROCHLORIDE
Strength EQ 300MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA216957
Applicant holder GLENMARK PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 10, 2023

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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