01 2CYSTEAMINE (CYSTEAMINE BITARTRATE)
02 4CYSTEAMINE BITARTRATE
03 1DICLOFENAC SODIUM
04 2ESOMEPRAZOLE MAGNESIUM; NAPROXEN
05 1FAMOTIDINE; IBUPROFEN
06 2GLYCEROL PHENYLBUTYRATE
07 1INEBILIZUMAB
08 1INTERFERON GAMMA-1B
09 1LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)
10 1PEGLOTICASE
11 3PREDNISONE
12 2SODIUM PHENYLBUTYRATE
13 1TEPROTUMUMAB-TRBW
01 11HORIZON
02 1HORIZON PHARMA
03 3HORIZON THERAP US
04 1HORIZON THERAPEUTICS IRELAND
05 6HORIZON THERAPEUTICS IRELAND DAC
01 2CAPSULE (DELAYED RELEASE)
02 2CAPSULE, DELAYED RELEASE;ORAL
03 2GRANULE, DELAYED RELEASE;ORAL
04 1INJECTABLE; INJECTION
05 1INJECTABLE;INJECTION
06 1LIQUID
07 1LIQUID;ORAL
08 1POWDER;ORAL
09 2SOLUTION
10 1SOLUTION;TOPICAL
11 5TABLET, DELAYED RELEASE;ORAL
12 2TABLET;ORAL
13 1VIAL; SINGLE-USE
01 11.1G/ML
02 11.1GM/ML
03 1100UG/0.5ML
04 110MG/ML
05 11MG
06 12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
07 1240MG/2.4ML
08 125MG
09 126.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
10 12MG
11 13GM/TEASPOONFUL
12 2500MG
13 15MG
14 175MG
15 18MG
16 1EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
17 1EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
18 1EQ 25MG BASE
19 1EQ 300MG BASE/PACKET
20 1EQ 75MG BASE
21 1EQ 75MG BASE/PACKET
01 5Canada
02 17USA
Regulatory Info :
Registration Country : Canada
CYSTEAMINE (CYSTEAMINE BITARTRATE)
Dosage Form : CAPSULE (DELAYED RELEASE...
Brand Name : PROCYSBI
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number : 2464713
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
CYSTEAMINE (CYSTEAMINE BITARTRATE)
Dosage Form : CAPSULE (DELAYED RELEASE...
Brand Name : PROCYSBI
Dosage Strength : 25MG
Packaging : 50
Approval Date :
Application Number : 2464705
Regulatory Info :
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE, DELAYED RELEASE...
Brand Name : PROCYSBI
Dosage Strength : EQ 25MG BASE
Packaging :
Approval Date : 2013-04-30
Application Number : 203389
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE, DELAYED RELEASE...
Brand Name : PROCYSBI
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2013-04-30
Application Number : 203389
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : GRANULE, DELAYED RELEASE...
Brand Name : PROCYSBI
Dosage Strength : EQ 75MG BASE/PACKET
Packaging :
Approval Date : 2020-02-14
Application Number : 213491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : GRANULE, DELAYED RELEASE...
Brand Name : PROCYSBI
Dosage Strength : EQ 300MG BASE/PACKET
Packaging :
Approval Date : 2020-02-14
Application Number : 213491
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;TOPICAL
Brand Name : PENNSAID
Dosage Strength : 2% **Federal Register ...
Packaging :
Approval Date : 2014-01-16
Application Number : 204623
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Dosage Form : TABLET, DELAYED RELEASE;...
Brand Name : VIMOVO
Dosage Strength : EQ 20MG BASE;500MG **F...
Packaging :
Approval Date : 2010-04-30
Application Number : 22511
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Dosage Form : TABLET, DELAYED RELEASE;...
Brand Name : VIMOVO
Dosage Strength : EQ 20MG BASE;375MG **F...
Packaging :
Approval Date : 2010-04-30
Application Number : 22511
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : DUEXIS
Dosage Strength : 26.6MG;800MG **Federal...
Packaging :
Approval Date : 2011-04-23
Application Number : 22519
Regulatory Info : DISCN
Registration Country : USA
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