Orange Book product

ACYCLOVIR 5%

Orange Book ANDA 209971 · TORRENT PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name ACYCLOVIR
Active ingredients ACYCLOVIR
Strength 5%
Dosage form OINTMENT
Route TOPICAL
Application ANDA209971
Applicant holder TORRENT PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 11, 2019

At a glance

  • 10–99 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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