Application 091084

Type
ANDA
Sponsor
WATSON LABS FLORIDA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTAN; HYDROCHLOROTHIAZIDETELMISARTAN; HYDROCHLOROTHIAZIDETABLET; ORAL40MG; 12.5MGNoNo
002TELMISARTAN; HYDROCHLOROTHIAZIDETELMISARTAN; HYDROCHLOROTHIAZIDETABLET; ORAL80MG; 12.5MGNoNo
003TELMISARTAN; HYDROCHLOROTHIAZIDETELMISARTAN; HYDROCHLOROTHIAZIDETABLET; ORAL80MG; 25MGNoNo

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.