Drug application

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN, HYDROCODONE BITARTRATE)

Drugs@FDA ANDA 040355 · STRIDES PHARMA INTL

Key facts

Drug name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active ingredients ACETAMINOPHEN, HYDROCODONE BITARTRATE
Application type ANDA
Application number 040355
Company STRIDES PHARMA INTL
Dosage forms TABLET, ORAL
Strength 325MG;10MG
Marketing status Discontinued
TE codes AA
Reference listed drug No
Latest submission status date May 31, 2000

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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