01 6ACTAVIS LABS FL
02 4AMNEAL PHARMS NY
03 6AUROBINDO PHARMA
04 4DR REDDYS LABS LTD
05 3HOFFMANN LA ROCHE
06 3MYLAN PHARMS INC
07 6SUN PHARM
08 6SUN PHARM INDS INC
09 4SUN PHARM INDS LTD
10 4TEVA PHARMS USA
11 8UPSHER SMITH LABS
12 4ZYDUS PHARMS
01 58CAPSULE;ORAL
01 9DISCN
02 49RX
01 6ABSORICA
02 6ABSORICA LD
03 3ACCUTANE
04 3AMNESTEEM
05 4CLARAVIS
06 24ISOTRETINOIN
07 4MYORISAN
08 4SOTRET
09 4ZENATANE
01 43No
02 15Yes
RLD : Yes
TE Code :
Brand Name : ACCUTANE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-05-07
Application Number : 18662
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ACCUTANE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-05-07
Application Number : 18662
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ACCUTANE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1983-03-28
Application Number : 18662
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AB2
Brand Name : ABSORICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Approval Date : 2012-05-25
Application Number : 21951
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB2
RLD : Yes
TE Code : AB2
Brand Name : ABSORICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG
Approval Date : 2012-05-25
Application Number : 21951
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB2
RLD : Yes
TE Code : AB2
Brand Name : ABSORICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 30MG
Approval Date : 2012-05-25
Application Number : 21951
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB2
RLD : Yes
TE Code : AB2
Brand Name : ABSORICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 40MG
Approval Date : 2012-05-25
Application Number : 21951
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB2
RLD : Yes
TE Code : AB2
Brand Name : ABSORICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 25MG
Approval Date : 2014-08-15
Application Number : 21951
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB2
RLD : Yes
TE Code : AB2
Brand Name : ABSORICA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 35MG
Approval Date : 2014-08-15
Application Number : 21951
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB2
RLD : No
TE Code : AB1
Brand Name : AMNESTEEM
Dosage Form : CAPSULE;ORAL
Dosage Strength : 10MG
Approval Date : 2002-11-08
Application Number : 75945
RX/OTC/DISCN : RX
RLD : No
TE Code : AB1
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