01 1BIRCH TRITERPENES
02 1CANGRELOR
03 3CLEVIDIPINE
04 5DEFERIPRONE
05 1ELAPEGADEMASE-LVLR
06 6LOMITAPIDE MESYLATE
07 1METRELEPTIN
08 10NICARDIPINE HYDROCHLORIDE
09 1OCTREOTIDE ACETATE
10 1PEGUNIGALSIDASE ALFA-IWXJ
11 1PORACTANT ALFA
12 1TOBRAMYCIN
13 1VELMANASE ALFA-TYCV
14 3ZILEUTON
01 1CAPSULE, DELAYED RELEASE;ORAL
02 3CAPSULE, EXTENDED RELEASE;ORAL
03 8CAPSULE;ORAL
04 3EMULSION;INTRAVENOUS
05 1GEL;TOPICAL
06 3INJECTABLE;INJECTION
07 4INJECTABLE;INTRAVENOUS
08 1POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
09 1POWDER;INTRAVENOUS
10 1SOLUTION;INHALATION
11 2SOLUTION;ORAL
12 1SUSPENSION;INTRATRACHEAL
13 1TABLET, EXTENDED RELEASE;ORAL
14 5TABLET;ORAL
15 1VIAL; SINGLE-USE
01 11.6MG/ML
02 110%
03 1100MG/ML
04 110MG
05 111.3MG
06 1125MG/250ML (0.5MG/ML)
07 21GM
08 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
09 120MG/10ML
10 220MG/200ML (0.1MG/ML)
11 125MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
12 125MG/50ML (0.5MG/ML)
13 1300MG
14 1300MG/4ML
15 230MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
16 240MG/200ML (0.2MG/ML)
17 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
18 1500MG
19 150MG/100ML (0.5MG/ML)
20 150MG/VIAL
21 1600MG
22 1600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
23 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
24 280MG/ML
25 1EQ 10MG BASE
26 2EQ 20MG BASE
27 1EQ 30MG BASE
28 1EQ 40MG BASE
29 1EQ 5MG BASE
30 1EQ 60MG BASE
01 13DISCN
02 18RX
03 5Blank
RLD : Yes
TE Code :
Dosage Form : GEL; TOPICAL
Proprietary Name : FILSUVEZ
Dosage Strength : 10%
Approval Date : 2023-12-18
Application Number : 215064
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : KENGREAL
Dosage Strength : 50MG/VIAL
Approval Date : 2015-06-22
Application Number : 204958
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : EMULSION; INTRAVENOUS
Proprietary Name : CLEVIPREX
Dosage Strength : 25MG/50ML (0.5MG/ML)
Approval Date : 2008-08-01
Application Number : 22156
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : EMULSION; INTRAVENOUS
Proprietary Name : CLEVIPREX
Dosage Strength : 50MG/100ML (0.5MG/ML)
Approval Date : 2008-08-01
Application Number : 22156
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : EMULSION; INTRAVENOUS
Proprietary Name : CLEVIPREX
Dosage Strength : 125MG/250ML (0.5MG/ML)
Approval Date : 2013-11-08
Application Number : 22156
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : FERRIPROX
Dosage Strength : 500MG
Approval Date : 2011-10-14
Application Number : 21825
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : FERRIPROX
Dosage Strength : 1GM
Approval Date : 2019-07-25
Application Number : 21825
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : FERRIPROX
Dosage Strength : 100MG/ML
Approval Date : 2015-09-09
Application Number : 208030
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; ORAL
Proprietary Name : FERRIPROX
Dosage Strength : 80MG/ML
Approval Date : 2018-04-20
Application Number : 208030
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : FERRIPROX
Dosage Strength : 1GM
Approval Date : 2020-05-19
Application Number : 212269
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
