Orange Book product

HYDRALAZINE HYDROCHLORIDE 25MG

Orange Book ANDA 205236 · SCIEGEN PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name HYDRALAZINE HYDROCHLORIDE
Active ingredients HYDRALAZINE HYDROCHLORIDE
Strength 25MG
Dosage form TABLET
Route ORAL
Application ANDA205236
Applicant holder SCIEGEN PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 26, 2017

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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