Orange Book product

PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Orange Book ANDA 207146 · APOTEX INC · Prescription

Key facts

Proprietary name PIPERACILLIN AND TAZOBACTAM
Active ingredients PIPERACILLIN SODIUM, TAZOBACTAM SODIUM
Strength EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA207146
Applicant holder APOTEX INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Mar 17, 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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