Product Details
WHO Product ID
ANDA 212579c USFDA
Status
Prequalified
INN, dosage form and strength
Atazanavir (sulfate) Capsules, hard 300mg
Basis of listing
Alternative Listing
Basis of alternative listing
USFDA - PEPFAR
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Applicant organization
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C
Packaging Type
Blister
Configuration
5x6
Shelf life (months)
36
Storage conditions
Do not store above 25°C
FPP Manufacturing Site(s)
Laurus Labs Limited
Unit-II, Plot No:19, 20 & 21, Western Sector, APSEZ, Gurajapalem Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India