01 2ACETAMINOPHEN; BUTALBITAL
02 3ACETAMINOPHEN; BUTALBITAL; CAFFEINE
03 1ALBUTEROL SULFATE
04 1ARIPIPRAZOLE
05 3BENZTROPINE MESYLATE
06 1CETIRIZINE HYDROCHLORIDE
07 1CLINDAMYCIN PHOSPHATE
08 1CLOBETASOL PROPIONATE
09 1CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
10 2CYPROHEPTADINE HYDROCHLORIDE
11 5ESTRADIOL
12 3FLUOCINOLONE ACETONIDE
13 1FLUOCINONIDE
14 3FLUVOXAMINE MALEATE
15 3GLIMEPIRIDE
16 2GLYCOPYRROLATE
17 1HALOBETASOL PROPIONATE
18 1HYDROCHLOROTHIAZIDE
19 1LEVETIRACETAM
20 1LIDOCAINE
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 1GEL;TOPICAL
04 5GEL;TRANSDERMAL
05 4INJECTABLE;INJECTION
06 2LOTION;TOPICAL
07 1OIL/DROPS;OTIC
08 2OIL;TOPICAL
09 2OINTMENT;TOPICAL
10 1PASTE;DENTAL
11 9SOLUTION;ORAL
12 2SOLUTION;TOPICAL
13 1SUPPOSITORY;RECTAL
14 6SYRUP;ORAL
15 29TABLET;ORAL
01 30.01%
02 10.025%
03 30.05%
04 20.1%
05 10.1% (0.25GM/PACKET)
06 10.1% (0.5GM/PACKET)
07 10.1% (0.75GM/PACKET)
08 10.1% (1.25GM/PACKET)
09 10.1% (1GM/PACKET)
10 20.5MG
11 2100MG
12 1100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
13 1100MG/5ML
14 2100MG/ML
15 110MG/5ML
16 110MG/5ML;6.25MG/5ML
17 212.5MG
18 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
19 1150MG
20 21GM
21 41MG
22 11MG/ML
23 1200MG
24 120MEQ/15ML
25 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
26 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
27 1240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
28 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
29 1250MG
30 1250MG/5ML
31 225MG
32 125MG/ML
33 42MG
34 12MG/5ML
35 1300MG
36 1300MG;50MG
37 1300MG;50MG;40MG
38 1325MG;50MG
39 2325MG;50MG;40MG
40 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**
41 140MEQ/15ML
42 24MG
43 15%
44 350MG
45 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
46 150MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
47 150MG/ML
48 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
49 35MG/5ML
50 16.25MG/5ML
51 175MG/ML
52 1EQ 1% BASE
53 1EQ 100MG BASE
54 1EQ 25MG BASE
55 1EQ 2MG BASE/5ML
56 1EQ 50MG BASE
01 31DISCN
02 1OTC
03 50RX
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 : 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
RLD : No
TE Code : AA
Dosage Form : TABLET; ORAL
Proprietary Name : BENZTROPINE MESYLATE
Dosage Strength : 2MG
Approval Date : 2025-02-11
Application Number : 212694
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
