Application 201616

Type
ANDA
Sponsor
CIPLA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDE; IRBESARTANHYDROCHLOROTHIAZIDE; IRBESARTANTABLET; ORAL12.5MG; 150MGNoNo
002HYDROCHLOROTHIAZIDE; IRBESARTANHYDROCHLOROTHIAZIDE; IRBESARTANTABLET; ORAL12.5MG; 300MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.