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FDA Approval

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FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Purdue Pharma LP
DUNS: 932323652
Effective Date
March 23, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Morphine(200 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Purdue Pharma LP

932323652

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Purdue Pharmaceuticals L.P.

Purdue Pharma LP

Purdue Pharma LP

132080875

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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Product Details

NDC Product Code
59011-264
Application Number
NDA019516
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 23, 2017
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBDClass: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT

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Product Details

NDC Product Code
59011-263
Application Number
NDA019516
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 23, 2017
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357Class: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT

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Product Details

NDC Product Code
59011-260
Application Number
NDA019516
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 23, 2017
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
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQKClass: IACT
LactoseInactive
Code: J2B2A4N98GClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT

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Product Details

NDC Product Code
59011-261
Application Number
NDA019516
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 23, 2017
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
D&C Red No. 7Inactive
Code: ECW0LZ41X8Class: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBDClass: IACT
LactoseInactive
Code: J2B2A4N98GClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT

MS Contin

Product Details

NDC Product Code
59011-262
Application Number
NDA019516
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 23, 2017
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
lactoseInactive
Code: J2B2A4N98GClass: IACT
D&C Red No. 30Inactive
Code: 2S42T2808BClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1
hydroxyethyl cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
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