Orange Book product

MICONAZOLE NITRATE COMBINATION PACK 2%,200MG

Orange Book ANDA 075329 · L PERRIGO CO · Over the counter

Key facts

Proprietary name MICONAZOLE NITRATE COMBINATION PACK
Active ingredients MICONAZOLE NITRATE
Strength 2%,200MG
Dosage form CREAM, SUPPOSITORY
Route TOPICAL, VAGINAL
Application ANDA075329
Applicant holder L PERRIGO CO
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 20, 1999

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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