Drug application

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

Drugs@FDA ANDA 203335 · DR REDDYS LABS SA

Key facts

Drug name BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Active ingredients ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE
Application type ANDA
Application number 203335
Company DR REDDYS LABS SA
Dosage forms CAPSULE, ORAL
Strength 325MG;50MG;40MG;30MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Oct 30, 2015

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None 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:

Browse all Drugs@FDA applications