Orange Book product

CLINDAMYCIN PHOSPHATE EQ 1% BASE

Orange Book ANDA 065049 · PADAGIS US LLC · Prescription

Key facts

Proprietary name CLINDAMYCIN PHOSPHATE
Active ingredients CLINDAMYCIN PHOSPHATE
Strength EQ 1% BASE
Dosage form SWAB
Route TOPICAL
Application ANDA065049
Applicant holder PADAGIS US LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 25, 2000

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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