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FDA Approval

Oxazepam

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

FDA Approval Summary

Company
TruPharma, LLC
DUNS: 078533947
Effective Date
April 30, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oxazepam(10 mg in 1 1)

Products3

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

Oxazepam

Product Details

NDC Product Code
52817-290
Application Number
ANDA071026
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 3, 2021
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 10 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT

Oxazepam

Product Details

NDC Product Code
52817-291
Application Number
ANDA071026
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 3, 2021
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 15 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Oxazepam

Product Details

NDC Product Code
52817-292
Application Number
ANDA071026
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 3, 2021
GELATINInactive
Code: 2G86QN327LClass: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 30 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
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