Orange Book product

NITROFURANTOIN MACROCRYSTALLINE 50MG

Orange Book ANDA 070248 · WATSON LABORATORIES INC · Discontinued

Key facts

Proprietary name NITROFURANTOIN MACROCRYSTALLINE
Active ingredients NITROFURANTOIN, MACROCRYSTALLINE
Strength 50MG
Dosage form CAPSULE
Route ORAL
Application ANDA070248
Applicant holder WATSON LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 24, 1988

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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