01 2ADALIMUMAB-ATTO
02 1AFLIBERCEPT-AYYH
03 7APREMILAST
04 1AVACOPAN
05 2BEVACIZUMAB-AWWB
06 1BLINATUMOMAB
07 3CARFILZOMIB
08 3CINACALCET HYDROCHLORIDE
09 4CYSTEAMINE BITARTRATE
10 10DARBEPOETIN ALFA
11 2DENOSUMAB
12 1DICLOFENAC SODIUM
13 1ECULIZUMAB-AEEB
14 7EPOETIN ALFA
15 1ERENUMAB-AOOE
16 2ESOMEPRAZOLE MAGNESIUM; NAPROXEN
17 2ETANERCEPT
18 3ETELCALCETIDE
19 1EVOLOCUMAB
20 1FAMOTIDINE; IBUPROFEN
21 4FILGRASTIM
22 1GLYCEROL PHENYLBUTYRATE
23 1INFLIXIMAB-AXXQ
24 1INTERFERON GAMMA-1B
25 1IVABRADINE
26 2IVABRADINE HYDROCHLORIDE
27 1LEVOMEPROMAZINE
28 1OXALIPLATIN
29 2PAMIDRONATE DISODIUM
30 3PANITUMUMAB
31 1PEGFILGRASTIM
32 1PEGLOTICASE
33 3PREDNISONE
34 1RITUXIMAB-ARRX
35 1ROMIPLOSTIM
36 1ROMOSOZUMAB-AQQG
37 2SODIUM PHENYLBUTYRATE
38 3SOTORASIB
39 2TARLATAMAB-DLLE
40 1TEPROTUMUMAB-TRBW
41 2THIOTEPA
42 2TRASTUZUMAB-ANNS
43 3USTEKINUMAB-AUUB
01 2CAPSULE, DELAYED RELEASE;ORAL
02 1CAPSULE;ORAL
03 2GRANULE, DELAYED RELEASE;ORAL
04 4INJECTABLE; INJECTION
05 3INJECTABLE; IV (INFUSION)
06 3INJECTABLE; SUBCUTANEOUS
07 18INJECTABLE;INJECTION
08 3INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
09 1LIQUID;ORAL
10 3POWDER;INTRAVENOUS
11 1POWDER;ORAL
12 3SOLUTION;INTRAVENOUS
13 1SOLUTION;ORAL
14 1SOLUTION;TOPICAL
15 4SYRINGE
16 5TABLET, DELAYED RELEASE;ORAL
17 1TABLET, EXTENDED RELEASE;ORAL
18 1TABLET;EXTENDED RELEASE
19 15TABLET;ORAL
20 2VIAL
21 5VIAL; INTRAVENOUS
22 3VIAL; MULTIDOSE
23 6VIAL; SINGLE-USE
24 6VIAL; SUBCUTANEOUS
25 1VIAL;SINGLE-DOSE
01 11.1GM/ML
02 110,000U/ML
03 1100MG/10ML(10MG/ML)
04 1100MG/4ML (25MG/ML)
05 1100MG/VIAL
06 1100UG/0.5ML
07 2100UG/ML
08 1105MG/1.17ML
09 310MG
10 110MG/2ML (5MG/ML)
11 110MG/VIAL
12 110ML/200MG
13 1120MG
14 1130MG/26ML
15 1140MG/ML
16 1150MG
17 115MG/VIAL
18 115MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
19 21MG
20 12 mg (0.05 mL of 40 mg/mL)
21 12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
22 12,000U/ML
23 12.5MG/0.5ML (2.5MG/0.5ML)
24 120,000/ML
25 120,000U/2ML
26 2200UG/ML
27 220MG
28 120MG/0.4ML
29 120MG/ML
30 120ML/400MG
31 1240MG
32 1250MCG/0.5ML; 500MCG/1ML.
33 125MG/VIAL
34 225UG/ML
35 126.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
36 12MG
37 13,000U/ML
38 1300MCG/1ML
39 1300MG/30ML(10MG/ML)
40 1300MGC/0.5ML
41 230MG
42 230MG/VIAL
43 1320MG
44 135MCG
45 13GM/TEASPOONFUL
46 14,000U/ML
47 140,000U/ML
48 1400MG/16ML (25MG/ML)
49 140MG/0.8ML
50 240UG/ML
51 1420MG
52 145MG/0.5ML
53 1480MCG/0.8ML
54 1480MCG/1.6ML
55 2500MG
56 150MG/ML
57 15MG
58 15MG/5ML (1MG/ML)
59 15MG/ML
60 15MG/ML (5MG/ML)
61 15ML/100MG
62 160MG/ML
63 160MG/VIAL
64 260UG/ML
65 16MG/0.6ML
66 270MG/ML
67 275MG
68 18MG
69 190MG/ML
70 190MG/VIAL
71 1EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
72 1EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
73 1EQ 25MG BASE
74 1EQ 300MG BASE/PACKET
75 1EQ 30MG BASE
76 1EQ 5MG BASE
77 1EQ 60MG BASE
78 1EQ 7.5MG BASE
79 1EQ 75MG BASE
80 1EQ 75MG BASE/PACKET
81 1EQ 90MG BASE
01 15DISCN
02 24RX
03 56Blank
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : AMJEVITA
Dosage Strength : 20MG/0.4ML
Approval Date :
Application Number : 761024
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : AMJEVITA
Dosage Strength : 40MG/0.8ML
Approval Date :
Application Number : 761024
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : PAVBLU
Dosage Strength : 2 mg (0.05 mL of 40 mg/m...
Approval Date :
Application Number : 761298
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : OTEZLA
Dosage Strength : 10MG
Approval Date : 2014-03-21
Application Number : 205437
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : OTEZLA
Dosage Strength : 20MG
Approval Date : 2014-03-21
Application Number : 205437
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : OTEZLA
Dosage Strength : 30MG
Approval Date : 2014-03-21
Application Number : 205437
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OTEZLA XR
Dosage Strength : 75MG
Approval Date : 2025-08-29
Application Number : 210745
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : OTEZLA
Dosage Strength : 20MG
Approval Date :
Application Number : 210745
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : OTEZLA
Dosage Strength : 30MG
Approval Date :
Application Number : 210745
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : TABLET; EXTENDED RELEASE
Proprietary Name : OTEZLA XR
Dosage Strength : 75MG
Approval Date :
Application Number : 210745
RX/OTC/DISCN :
RLD :
TE Code :
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