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FDA Approval

REYATAZ

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atazanavir(50 mg in 1 1)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

REYATAZ

Product Details

NDC Product Code
0003-3638
Application Number
NDA206352
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 24, 2020
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
Code: 4MT4VIE29PClass: ACTIMQuantity: 50 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT

REYATAZ

Product Details

NDC Product Code
0003-3631
Application Number
NDA021567
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 24, 2020
Code: 4MT4VIE29PClass: ACTIMQuantity: 200 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT

REYATAZ

Product Details

NDC Product Code
0003-3624
Application Number
NDA021567
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 24, 2020
Code: 4MT4VIE29PClass: ACTIMQuantity: 150 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

REYATAZ

Product Details

NDC Product Code
0003-3622
Application Number
NDA021567
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 24, 2020
Code: 4MT4VIE29PClass: ACTIMQuantity: 300 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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