01 3ACTAVIS LABS FL INC
02 1ALKERMES GAINESVILLE
03 1BAYER
04 3MISEMER
05 3MYLAN
06 1NOVARTIS
07 1PERRIGO
08 4RISING
09 3TEVA
10 3WYETH AYERST
11 1WYETH CONS
12 3WYETH PHARMS INC
01 10CAPSULE, EXTENDED RELEASE;ORAL
02 13CAPSULE;ORAL
03 1FILM;ORAL
04 3TABLET;ORAL
01 22DISCN
02 5RX
01 1ACTRON
02 18KETOPROFEN
03 1NEXCEDE
04 3ORUDIS
05 1ORUDIS KT
06 3ORUVAIL
01 20No
02 7Yes
RLD : No
TE Code :
Brand Name : ACTRON
Dosage Form : TABLET;ORAL
Dosage Strength : 12.5MG
Approval Date : 1995-10-06
Application Number : 20499
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : NEXCEDE
Dosage Form : FILM;ORAL
Dosage Strength : 12.5MG
Approval Date : 2009-11-25
Application Number : 22470
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : KETOPROFEN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 25MG
Approval Date : 1992-12-22
Application Number : 73515
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUDIS
Dosage Form : CAPSULE;ORAL
Dosage Strength : 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1987-07-31
Application Number : 18754
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUDIS
Dosage Form : CAPSULE;ORAL
Dosage Strength : 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1986-01-09
Application Number : 18754
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUDIS
Dosage Form : CAPSULE;ORAL
Dosage Strength : 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1986-01-09
Application Number : 18754
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUVAIL
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1993-09-24
Application Number : 19816
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUVAIL
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1995-02-08
Application Number : 19816
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUVAIL
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1995-02-08
Application Number : 19816
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ORUDIS KT
Dosage Form : TABLET;ORAL
Dosage Strength : 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1995-10-06
Application Number : 20429
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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