01 1AM REGENT
02 2AQUESTIVE
03 2AUROBINDO PHARMA
04 2BARR
05 4CHARTWELL MOLECULES
06 2GLENMARK PHARMS LTD
07 2IPCA LABS LTD
08 2MYLAN
09 2NESHER PHARMS
10 4SANDOZ
11 2SUN PHARM INDS
12 2SUN PHARM INDS LTD
13 2TEVA
01 2FILM;ORAL
02 1INJECTABLE; INJECTION
03 26TABLET, ORALLY DISINTEGRATING;ORAL
01 14DISCN
02 14RX
03 1Blank
01 25ONDANSETRON
02 2ZOFRAN ODT
03 2ZUPLENZ
01 24No
02 4Yes
03 1Blank
RLD : Yes
TE Code :
Brand Name : ZUPLENZ
Dosage Form : FILM;ORAL
Dosage Strength : 4MG
Approval Date : 2010-07-02
Application Number : 22524
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZUPLENZ
Dosage Form : FILM;ORAL
Dosage Strength : 8MG
Approval Date : 2010-07-02
Application Number : 22524
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ONDANSETRON
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 4MG
Approval Date : 2007-06-25
Application Number : 76693
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ONDANSETRON
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 8MG
Approval Date : 2007-06-25
Application Number : 76693
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ONDANSETRON
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 16MG
Approval Date : 2006-12-26
Application Number : 77406
RX/OTC/DISCN : RX
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ONDANSETRON
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 24MG
Approval Date : 2006-12-26
Application Number : 77406
RX/OTC/DISCN : RX
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : ZOFRAN ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1999-01-27
Application Number : 20781
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZOFRAN ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1999-01-27
Application Number : 20781
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ONDANSETRON
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 4MG
Approval Date : 2007-06-25
Application Number : 76810
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ONDANSETRON
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 8MG
Approval Date : 2007-06-25
Application Number : 76810
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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