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
67544-268Application Number
ANDA072252Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 31, 2014CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 15 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Oxazepam
Product Details
NDC Product Code
67544-117Application Number
ANDA072251Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 31, 2014STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
OxazepamActive
Code: 6GOW6DWN2AClass: ACTIBQuantity: 10 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT