Oxazepam

Products3

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

Product Details

NDC Product Code

0228-2069

Application Number

ANDA072253

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

OxazepamActive

Code: 6GOW6DWN2AClass: ACTIBQuantity: 15 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 2 ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Oxazepam

Product Details

NDC Product Code

0228-2067

Application Number

ANDA072253

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

OxazepamActive

Code: 6GOW6DWN2AClass: ACTIBQuantity: 10 mg in 1 1

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FD&C BLUE NO. 2 ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

Oxazepam

Product Details

NDC Product Code

0228-2073

Application Number

ANDA072253

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

OxazepamActive

Code: 6GOW6DWN2AClass: ACTIBQuantity: 30 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ETHYL ACETATEInactive

Code: 76845O8NMZClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

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Oxazepam

FDA Approval Summary

Products3

Oxazepam

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Oxazepam

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Oxazepam

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