Drug application

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN, BUTALBITAL, CAFFEINE and 1 more)

Drugs@FDA ANDA 074951 · STEVENS J

Key facts

Drug name BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Active ingredients ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE
Application type ANDA
Application number 074951
Company STEVENS J
Dosage forms CAPSULE, ORAL
Strength 325MG;50MG;40MG;30MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 31, 1998

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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