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FDA Approval

NUCYNTA

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

FDA Approval Summary

Company
Stat Rx USA
DUNS: 786036330
Effective Date
October 27, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tapentadol(50 mg in 1 1)

Manufacturing Establishments1

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

Stat Rx USA

Stat Rx USA

786036330

Products2

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

NUCYNTA

Product Details

NDC Product Code
16590-863
Application Number
NDA022304
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 29, 2010
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Code: 71204KII53Class: ACTIMQuantity: 50 mg in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyvinyl alcoholInactive
Code: 532B59J990Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT

NUCYNTA

Product Details

NDC Product Code
16590-289
Application Number
NDA022304
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
March 29, 2010
Code: 71204KII53Class: ACTIMQuantity: 100 mg in 1 1
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyvinyl alcoholInactive
Code: 532B59J990Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
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