01 6ACTAVIS ELIZABETH
02 1ACTAVIS LABS UT INC
03 3ALKEM LABS LTD
04 9COLLEGIUM PHARM INC
05 2HUMANWELL PHARMACEUTICAL US INC
06 2RHODES PHARMS
07 3ROXANE
08 4WEST-WARD PHARMS INT
01 2SOLUTION;ORAL
02 14TABLET, EXTENDED RELEASE;ORAL
03 2TABLET; ORAL
04 12TABLET;ORAL
01 1DISCN
02 8RX
03 21Blank
01 4NUCYNTA
02 5NUCYNTA ER
03 16TAPENTADOL
04 5TAPENTADOL HYDROCHLORIDE
01 9Yes
02 21Blank
RLD :
TE Code :
Brand Name : TAPENTADOL
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG
Approval Date :
Application Number : 204971
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2008-11-20
Application Number : 22304
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 75MG BASE
Approval Date : 2008-11-20
Application Number : 22304
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2008-11-20
Application Number : 22304
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2011-08-25
Application Number : 200533
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2011-08-25
Application Number : 200533
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 150MG BASE
Approval Date : 2011-08-25
Application Number : 200533
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2011-08-25
Application Number : 200533
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 250MG BASE
Approval Date : 2011-08-25
Application Number : 200533
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NUCYNTA
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2012-10-15
Application Number : 203794
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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