Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Sun Pharmaceutical Industries, Inc.
146974886
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Frontida BioPharm, Inc.
Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc.
080243260
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Temazepam
Product Details
NDC Product Code
53489-651Application Number
ANDA071175Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 26, 2019FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TemazepamActive
Code: CHB1QD2QSSClass: ACTIBQuantity: 30 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Temazepam
Product Details
NDC Product Code
53489-650Application Number
ANDA071175Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 26, 2019SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: 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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TemazepamActive
Code: CHB1QD2QSSClass: ACTIBQuantity: 22.5 mg in 1 1
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Temazepam
Product Details
NDC Product Code
53489-648Application Number
ANDA078581Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 26, 2019MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TemazepamActive
Code: CHB1QD2QSSClass: ACTIBQuantity: 7.5 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
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Temazepam
Product Details
NDC Product Code
53489-649Application Number
ANDA071175Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 26, 2019FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TemazepamActive
Code: CHB1QD2QSSClass: ACTIBQuantity: 15 mg in 1 1