Application 202172

Type
NDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSUVASTATIN ZINCROSUVASTATIN ZINCTABLET; ORAL5MGNoNo
002ROSUVASTATIN ZINCROSUVASTATIN ZINCTABLET; ORAL10MGNoNo
003ROSUVASTATIN ZINCROSUVASTATIN ZINCTABLET; ORAL20MGNoNo
004ROSUVASTATIN ZINCROSUVASTATIN ZINCTABLET; ORAL40MGNoNo

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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32200ORIG2016-02-16
32199ORIG2011-08-08