TEXOTINE, DULOXETINE GXP, DULOXETINE AP, DYBALTINE, DYMBALT, DYBALTINE, DYLOXA (Generic Partners Pty Ltd)
Product name
TEXOTINE, DULOXETINE GXP, DULOXETINE AP, DYBALTINE, DYMBALT, DYBALTINE, DYLOXA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
204 working days (255)
Active ingredients
Duloxetine hydrochloride
Registration type
New generic medicine
Indication
TEXOTINE, DULOXETINE GXP, DULOXETINE AP, DYBALTINE, DYMBALT, DYBALTINE, DYLOXA (capsules) is indicated for the treatment of:
- major depressive disorder (MDD)
- diabetic peripheral neuropathic pain (DPNP)
- generalised anxiety disorder (GAD).