MedPath
FDA Approval

MS Contin

December 27, 2023

HUMAN PRESCRIPTION DRUG LABEL

Morphine(200 mg in 1 1)

Products (5)

MS Contin

42858-900

NDA019516

NDA (C73594)

ORAL

December 27, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBDClass: IACT
hydroxypropyl cellulose, unspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT

MS Contin

42858-631

NDA019516

NDA (C73594)

ORAL

December 27, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
D&C Red No. 7Inactive
Code: ECW0LZ41X8Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBDClass: IACT
lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT

MS Contin

42858-799

NDA019516

NDA (C73594)

ORAL

December 27, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357Class: IACT

MS Contin

42858-515

NDA019516

NDA (C73594)

ORAL

December 27, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQKClass: IACT
lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT

MS Contin

42858-760

NDA019516

NDA (C73594)

ORAL

December 27, 2023

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
D&C Red No. 30Inactive
Code: 2S42T2808BClass: IACT
hydroxypropyl cellulose, unspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT
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