Drug application

CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)

Drugs@FDA ANDA 090738 · MYLAN PHARMS INC

Key facts

Drug name CYCLOBENZAPRINE HYDROCHLORIDE
Active ingredients CYCLOBENZAPRINE HYDROCHLORIDE
Application type ANDA
Application number 090738
Company MYLAN PHARMS INC
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 15MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Apr 24, 2013

At a glance

  • 1–9 Submissions
  • None Label versions
  • None Products
  • None Therapeutic equivalents

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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

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