Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products2
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
43353-980Application Number
ANDA071814Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 16, 2014OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 30 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
Oxazepam
Product Details
NDC Product Code
43353-965Application Number
ANDA071813Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 16, 2014OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 10 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT