MedPath
FDA Approval

MORPHINE SULFATE

January 30, 2023

HUMAN PRESCRIPTION DRUG LABEL

Morphine(100 mg in 1 1)

Manufacturing Establishments (1)

SpecGx LLC

SpecGx LLC

163205300

Products (5)

MORPHINE SULFATE

0406-8390

ANDA076438

ANDA (C73584)

ORAL

January 30, 2023

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT

MORPHINE SULFATE

0406-8315

ANDA076412

ANDA (C73584)

ORAL

January 30, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

MORPHINE SULFATE

0406-8380

ANDA076412

ANDA (C73584)

ORAL

January 30, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

MORPHINE SULFATE

0406-8330

ANDA076412

ANDA (C73584)

ORAL

January 30, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8Class: IACT

MORPHINE SULFATE

0406-8320

ANDA076438

ANDA (C73584)

ORAL

January 30, 2023

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
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