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01 1ACAMPROSATE CALCIUM
02 1ACETAMINOPHEN; IBUPROFEN
03 1AMANTADINE HYDROCHLORIDE
04 2AMPHETAMINE SULFATE
05 2APIXABAN
06 1ATOVAQUONE
07 1AZELASTINE HYDROCHLORIDE
08 3AZITHROMYCIN
09 2BENZONATATE
10 1BEXAROTENE
11 1BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
12 2CALCITRIOL
13 1CARBAMAZEPINE
14 5CETIRIZINE HYDROCHLORIDE
15 1CEVIMELINE HYDROCHLORIDE
16 4CIMETIDINE
17 3CLOBAZAM
18 1COLESEVELAM HYDROCHLORIDE
19 3DEFERASIROX
20 3DEXAMETHASONE
21 2DEXMETHYLPHENIDATE HYDROCHLORIDE
22 1DICLOFENAC POTASSIUM
23 1DICYCLOMINE HYDROCHLORIDE
24 1DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
25 3DOFETILIDE
26 2DOXYCYCLINE HYCLATE
27 1DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
28 3DROXIDOPA
29 1ENALAPRIL MALEATE
30 1ERGOCALCIFEROL
31 1ETHOSUXIMIDE
32 1FAMOTIDINE
33 1FINGOLIMOD HYDROCHLORIDE
34 5FLUVOXAMINE MALEATE
35 3GRANISETRON HYDROCHLORIDE
36 1HYDROXYZINE HYDROCHLORIDE
37 2IBUPROFEN
38 2IVABRADINE HYDROCHLORIDE
39 1KETOROLAC TROMETHAMINE
40 1LEVETIRACETAM
41 1LIDOCAINE HYDROCHLORIDE
42 4LOPERAMIDE HYDROCHLORIDE
43 1LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
44 1LORATADINE
45 1LORATADINE; PSEUDOEPHEDRINE SULFATE
46 1MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
47 1METFORMIN HYDROCHLORIDE
48 2METHIMAZOLE
49 3METHYLPHENIDATE HYDROCHLORIDE
50 1NAPROXEN SODIUM
51 2NICARDIPINE HYDROCHLORIDE
52 1NIMODIPINE
53 1OXCARBAZEPINE
54 3OXYBUTYNIN CHLORIDE
55 3PARICALCITOL
56 2POTASSIUM CITRATE
57 2PROCHLORPERAZINE MALEATE
58 2PROGESTERONE
59 1RUFINAMIDE
60 1SEVELAMER CARBONATE
61 4TERAZOSIN HYDROCHLORIDE
62 2TETRABENAZINE
63 2THEOPHYLLINE
64 1TRANEXAMIC ACID
65 4VALPROIC ACID
66 3ZONISAMIDE
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01 3CAPSULE, DELAYED RELEASE;ORAL
02 2CAPSULE, EXTENDED RELEASE;ORAL
03 47CAPSULE;ORAL
04 2FOR SUSPENSION;ORAL
05 3INJECTABLE;INJECTION
06 1JELLY;TOPICAL
07 6SOLUTION;ORAL
08 1SPRAY, METERED;NASAL
09 4SUSPENSION;ORAL
10 2SYRUP;ORAL
11 2TABLET, DELAYED RELEASE;ORAL
12 8TABLET, EXTENDED RELEASE;ORAL
13 3TABLET, FOR SUSPENSION;ORAL
14 39TABLET;ORAL
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01 10.125MG
02 10.137MG/SPRAY
03 10.25MCG
04 10.25MG
05 10.5MCG
06 10.5MG
07 11.6GM/BOT;3.13GM/BOT;17.5GM/BOT
08 7100MG
09 1100MG/ML
10 110MEQ
11 1010MG
12 110MG/5ML
13 110MG;10MG
14 110MG;240MG
15 112.5MG
16 1125MG
17 1125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
18 1150MG
19 115MEQ
20 115MG
21 11MCG
22 11MG
23 11MG/7.5ML
24 11MG/ML
25 12%
26 12.5MG
27 12.5MG/ML
28 6200MG
29 420MG
30 3250MG
31 1250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
32 1250MG;125MG
33 425MG
34 125MG;EQ 200MG FREE ACID AND POTASSIUM SALT
35 12MCG
36 32MG
37 12MG/5ML;10MG/5ML;30MG/5ML
38 12MG;125MG
39 3300MG
40 1300MG/5ML
41 330MG
42 1333MG
43 1400MG
44 140MG/5ML
45 140MG/ML
46 1450MG
47 14MCG
48 14MG
49 150,000 IU
50 1500MG
51 1500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
52 1500MG/5ML
53 250MG
54 85MG
55 15MG/5ML
56 1625MG
57 1650MG
58 16MG
59 1750MG/5ML
60 175MG
61 1800MG
62 1800MG/PACKET
63 1EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
64 1EQ 0.5MG BASE
65 1EQ 100MG BASE
66 2EQ 10MG BASE
67 1EQ 1MG BASE
68 1EQ 1MG BASE/ML (EQ 1MG BASE/ML)
69 1EQ 200MG BASE
70 1EQ 200MG FREE ACID AND POTASSIUM SALT
71 1EQ 250MG BASE
72 1EQ 2MG BASE
73 1EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
74 1EQ 500MG BASE
75 1EQ 50MG BASE
76 3EQ 5MG BASE
77 1EQ 600MG BASE
78 1EQ 7.5MG BASE
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01 12DISCN
02 14OTC
03 95RX
04 2Blank
RLD :
TE Code :
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Proprietary Name : ACAMPROSATE CALCIUM
Dosage Strength : 333MG
Approval Date :
Application Number : 219904
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND IBUPRO...
Dosage Strength : 250MG;125MG
Approval Date : 2023-08-01
Application Number : 216999
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code : AB
Dosage Form : CAPSULE; ORAL
Proprietary Name : AMANTADINE HYDROCHLORIDE
Dosage Strength : 100MG
Approval Date : 2008-05-29
Application Number : 78720
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : AMPHETAMINE SULFATE
Dosage Strength : 5MG
Approval Date : 2019-11-22
Application Number : 212919
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : AMPHETAMINE SULFATE
Dosage Strength : 10MG
Approval Date : 2019-11-22
Application Number : 212919
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : APIXABAN
Dosage Strength : 2.5MG
Approval Date : 2020-04-08
Application Number : 210152
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : APIXABAN
Dosage Strength : 5MG
Approval Date : 2020-04-08
Application Number : 210152
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Dosage Form : SUSPENSION; ORAL
Proprietary Name : ATOVAQUONE
Dosage Strength : 750MG/5ML
Approval Date : 2021-03-30
Application Number : 212918
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Dosage Form : SPRAY, METERED; NASAL
Proprietary Name : AZELASTINE HYDROCHLORIDE
Dosage Strength : 0.137MG/SPRAY
Approval Date : 2015-07-28
Application Number : 90176
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AZITHROMYCIN
Dosage Strength : EQ 600MG BASE
Approval Date : 2018-12-26
Application Number : 209999
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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