Drug application

SYNALGOS-DC (ASPIRIN, CAFFEINE, DIHYDROCODEINE BITARTRATE)

Drugs@FDA NDA 011483 · SUN PHARM INDUSTRIES

Key facts

Drug name SYNALGOS-DC
Active ingredients ASPIRIN, CAFFEINE, DIHYDROCODEINE BITARTRATE
Application type NDA
Application number 011483
Company SUN PHARM INDUSTRIES
Dosage forms CAPSULE, ORAL
Strength 356.4MG;30MG;16MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 4 - New Combination
Latest submission status date Jul 7, 1958

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No 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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