01 4CYSTEAMINE BITARTRATE
02 1DICLOFENAC SODIUM
03 2ESOMEPRAZOLE MAGNESIUM; NAPROXEN
04 1FAMOTIDINE; IBUPROFEN
05 1GLYCEROL PHENYLBUTYRATE
06 1INTERFERON GAMMA-1B
07 1PEGLOTICASE
08 3PREDNISONE
09 2SODIUM PHENYLBUTYRATE
10 1TEPROTUMUMAB-TRBW
01 2CAPSULE, DELAYED RELEASE;ORAL
02 2GRANULE, DELAYED RELEASE;ORAL
03 1INJECTABLE; INJECTION
04 1INJECTABLE;INJECTION
05 1LIQUID;ORAL
06 1POWDER;ORAL
07 1SOLUTION;TOPICAL
08 5TABLET, DELAYED RELEASE;ORAL
09 2TABLET;ORAL
10 1VIAL; SINGLE-USE
01 11.1GM/ML
02 1100UG/0.5ML
03 11MG
04 12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
05 126.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
06 12MG
07 13GM/TEASPOONFUL
08 2500MG
09 15MG
10 18MG
11 1EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
12 1EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
13 1EQ 25MG BASE
14 1EQ 300MG BASE/PACKET
15 1EQ 75MG BASE
16 1EQ 75MG BASE/PACKET
01 7DISCN
02 7RX
03 3Blank
RLD : Yes
TE Code :
Dosage Form : CAPSULE, DELAYED RELEASE; ORAL
Proprietary Name : PROCYSBI
Dosage Strength : EQ 25MG BASE
Approval Date : 2013-04-30
Application Number : 203389
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : CAPSULE, DELAYED RELEASE; ORAL
Proprietary Name : PROCYSBI
Dosage Strength : EQ 75MG BASE
Approval Date : 2013-04-30
Application Number : 203389
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : GRANULE, DELAYED RELEASE; ORAL
Proprietary Name : PROCYSBI
Dosage Strength : EQ 75MG BASE/PACKET
Approval Date : 2020-02-14
Application Number : 213491
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : GRANULE, DELAYED RELEASE; ORAL
Proprietary Name : PROCYSBI
Dosage Strength : EQ 300MG BASE/PACKET
Approval Date : 2020-02-14
Application Number : 213491
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; TOPICAL
Proprietary Name : PENNSAID
Dosage Strength : 2% **Federal Register de...
Approval Date : 2014-01-16
Application Number : 204623
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Proprietary Name : VIMOVO
Dosage Strength : EQ 20MG BASE;500MG **Fed...
Approval Date : 2010-04-30
Application Number : 22511
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Proprietary Name : VIMOVO
Dosage Strength : EQ 20MG BASE;375MG **Fed...
Approval Date : 2010-04-30
Application Number : 22511
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : DUEXIS
Dosage Strength : 26.6MG;800MG **Federal R...
Approval Date : 2011-04-23
Application Number : 22519
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : LIQUID; ORAL
Proprietary Name : RAVICTI
Dosage Strength : 1.1GM/ML
Approval Date : 2013-02-01
Application Number : 203284
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Dosage Form : VIAL; SINGLE-USE
Proprietary Name : ACTIMMUNE
Dosage Strength : 100UG/0.5ML
Approval Date :
Application Number : 103836
RX/OTC/DISCN :
RLD :
TE Code :
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