01 4CYSTEAMINE BITARTRATE
02 1DICLOFENAC SODIUM
03 2ESOMEPRAZOLE MAGNESIUM; NAPROXEN
04 1FAMOTIDINE; IBUPROFEN
05 2GLYCEROL PHENYLBUTYRATE
06 1INTERFERON GAMMA-1B
07 1LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)
08 1PEGLOTICASE
09 3PREDNISONE
10 2SODIUM PHENYLBUTYRATE
11 1TEPROTUMUMAB-TRBW
01 11HORIZON
02 1HORIZON PHARMA
03 3HORIZON THERAP US
04 1HORIZON THERAPEUTICS IRELAND
05 3HORIZON THERAPEUTICS IRELAND DAC
01 2CAPSULE, DELAYED RELEASE;ORAL
02 2GRANULE, DELAYED RELEASE;ORAL
03 1INJECTABLE; INJECTION
04 1INJECTABLE;INJECTION
05 1LIQUID
06 1LIQUID;ORAL
07 1POWDER;ORAL
08 1SOLUTION
09 1SOLUTION;TOPICAL
10 5TABLET, DELAYED RELEASE;ORAL
11 2TABLET;ORAL
12 1VIAL; SINGLE-USE
01 11.1G/ML
02 11.1GM/ML
03 1100UG/0.5ML
04 11MG
05 12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
06 1240MG/2.4ML
07 126.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
08 12MG
09 13GM/TEASPOONFUL
10 2500MG
11 15MG
12 18MG
13 1EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
14 1EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
15 1EQ 25MG BASE
16 1EQ 300MG BASE/PACKET
17 1EQ 75MG BASE
18 1EQ 75MG BASE/PACKET
01 2Canada
02 17USA
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
Regulatory Info : RX
Registration Country : USA
Dosage Form : LIQUID;ORAL
Brand Name : RAVICTI
Dosage Strength : 1.1GM/ML
Packaging :
Approval Date : 2013-02-01
Application Number : 203284
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Dosage Form : LIQUID
Brand Name : RAVICTI
Dosage Strength : 1.1G/ML
Packaging : 25ML
Approval Date :
Application Number : 2453304
Regulatory Info :
Registration Country : Canada
