01 7ACCORD HLTHCARE
02 5ACTAVIS ELIZABETH
03 5ALEMBIC
04 7ALEMBIC LTD
05 12CHARTWELL RX
06 7COSETTE
07 5DR REDDYS LABS LTD
08 7EPIC PHARMA LLC
09 13GLAXOSMITHKLINE LLC
10 7GLENMARK PHARMS LTD
11 7HIKMA
12 7MLV
13 6MYLAN PHARMS INC
14 7NORVIUM BIOSCIENCE
15 7ORBION PHARMS
16 12PRINSTON INC
17 5SANDOZ INC
18 5WATSON LABS INC
19 7ZYDUS LIFESCIENCES
01 47TABLET, EXTENDED RELEASE;ORAL
02 91TABLET;ORAL
01 52DISCN
02 86RX
01 7REQUIP
02 6REQUIP XL
03 125ROPINIROLE HYDROCHLORIDE
01 125No
02 13Yes
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-19
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-19
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-19
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-19
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1997-09-19
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1999-01-27
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1999-01-27
Application Number : 20658
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP XL
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2008-06-13
Application Number : 22008
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP XL
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2008-06-13
Application Number : 22008
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : REQUIP XL
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2008-06-13
Application Number : 22008
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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