Orange Book product

CLINDAMYCIN PHOSPHATE EQ 1% BASE

Orange Book ANDA 208767 · ZYDUS LIFESCIENCES LTD · Prescription

Key facts

Proprietary name CLINDAMYCIN PHOSPHATE
Active ingredients CLINDAMYCIN PHOSPHATE
Strength EQ 1% BASE
Dosage form SOLUTION
Route TOPICAL
Application ANDA208767
Applicant holder ZYDUS LIFESCIENCES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 16, 2018

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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