01 2ACETAMINOPHEN; BUTALBITAL
02 3ACETAMINOPHEN; BUTALBITAL; CAFFEINE
03 1ALBUTEROL SULFATE
04 1ARIPIPRAZOLE
05 1ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
06 3BENZTROPINE MESYLATE
07 1CETIRIZINE HYDROCHLORIDE
08 1CLOBETASOL PROPIONATE
09 1CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
10 2CYPROHEPTADINE HYDROCHLORIDE
11 3FLUOCINOLONE ACETONIDE
12 1FLUOCINONIDE
13 3FLUVOXAMINE MALEATE
14 3GLIMEPIRIDE
15 2GLYCOPYRROLATE
16 1HALOBETASOL PROPIONATE
17 1HYDROCHLOROTHIAZIDE
18 1LEVETIRACETAM
19 1LIDOCAINE
20 1LIDOCAINE HYDROCHLORIDE
21 7MEPERIDINE HYDROCHLORIDE
22 1MESALAMINE
23 1METHENAMINE HIPPURATE
24 2METHYLPHENIDATE HYDROCHLORIDE
25 3MEXILETINE HYDROCHLORIDE
26 2OXYCODONE HYDROCHLORIDE
27 8POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
28 2POTASSIUM CHLORIDE
29 4PROMETHAZINE HYDROCHLORIDE
30 1PROPYLTHIOURACIL
31 3REPAGLINIDE
32 1RITONAVIR
33 2SELEGILINE HYDROCHLORIDE
34 3SERTRALINE HYDROCHLORIDE
35 3TRIAMCINOLONE ACETONIDE
36 1URSODIOL
37 1VALPROIC ACID
01 9CAPSULE;ORAL
02 8FOR SOLUTION;ORAL
03 4INJECTABLE;INJECTION
04 2LOTION;TOPICAL
05 1OIL/DROPS;OTIC
06 2OIL;TOPICAL
07 2OINTMENT;TOPICAL
08 1PASTE;DENTAL
09 10SOLUTION;ORAL
10 2SOLUTION;TOPICAL
11 1SUPPOSITORY;RECTAL
12 6SYRUP;ORAL
13 30TABLET;ORAL
01 30.01%
02 10.025%
03 10.025MG;2.5MG
04 30.05%
05 20.1%
06 20.5MG
07 2100MG
08 1100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
09 1100MG/5ML
10 2100MG/ML
11 110MG/5ML
12 110MG/5ML;6.25MG/5ML
13 212.5MG
14 1120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
15 1150MG
16 21GM
17 41MG
18 11MG/ML
19 12%
20 1200MG
21 120MEQ/15ML
22 2227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
23 1227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
24 1240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
25 2240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
26 1250MG
27 1250MG/5ML
28 225MG
29 125MG/ML
30 42MG
31 12MG/5ML
32 1300MG
33 1300MG;50MG
34 1300MG;50MG;40MG
35 1325MG;50MG
36 2325MG;50MG;40MG
37 1360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
38 140MEQ/15ML
39 24MG
40 15%
41 350MG
42 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
43 150MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
44 150MG/ML
45 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
46 35MG/5ML
47 16.25MG/5ML
48 175MG/ML
49 1EQ 100MG BASE
50 1EQ 25MG BASE
51 1EQ 2MG BASE/5ML
52 1EQ 50MG BASE
01 32DISCN
02 1OTC
03 44RX
04 1Blank
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL AND ACETAMINO...
Dosage Strength : 325MG;50MG
Approval Date : 2024-01-18
Application Number : 214291
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL AND ACETAMINO...
Dosage Strength : 300MG;50MG
Approval Date : 2024-02-01
Application Number : 214305
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 2024-01-18
Application Number : 214287
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 300MG;50MG;40MG
Approval Date : 2024-02-08
Application Number : 214288
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 2024-03-12
Application Number : 216376
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
Dosage Form : SYRUP; ORAL
Proprietary Name : ALBUTEROL SULFATE
Dosage Strength : EQ 2MG BASE/5ML
Approval Date : 2019-09-06
Application Number : 212197
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
Dosage Form : SOLUTION; ORAL
Proprietary Name : ARIPIPRAZOLE
Dosage Strength : 1MG/ML
Approval Date : 2025-10-22
Application Number : 215582
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code :
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Dosage Form : TABLET; ORAL
Proprietary Name : DIPHENOXYLATE HYDROCHLOR...
Dosage Strength : 0.025MG;2.5MG
Approval Date : 2018-08-31
Application Number : 210571
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : BENZTROPINE MESYLATE
Dosage Strength : 0.5MG
Approval Date : 2025-02-11
Application Number : 212694
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : BENZTROPINE MESYLATE
Dosage Strength : 1MG
Approval Date : 2025-02-11
Application Number : 212694
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
