Orange Book product

GRISEOFULVIN 125MG/5ML

Orange Book ANDA 065354 · CIPLA LTD · Prescription

Key facts

Proprietary name GRISEOFULVIN
Active ingredients GRISEOFULVIN, MICROSIZE
Strength 125MG/5ML
Dosage form SUSPENSION
Route ORAL
Application ANDA065354
Applicant holder CIPLA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 10, 2007

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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