01 2ACETAMINOPHEN; BUTALBITAL
02 3ACETAMINOPHEN; BUTALBITAL; CAFFEINE
03 1ALBUTEROL SULFATE
04 1CETIRIZINE HYDROCHLORIDE
05 1CLINDAMYCIN PHOSPHATE
06 1CLOBETASOL PROPIONATE
07 1CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
08 2CYPROHEPTADINE HYDROCHLORIDE
09 5ESTRADIOL
10 3FLUOCINOLONE ACETONIDE
11 2GLYCOPYRROLATE
12 1HALOBETASOL PROPIONATE
13 1LEVETIRACETAM
14 1LIDOCAINE
15 7MEPERIDINE HYDROCHLORIDE
16 2METHYLPHENIDATE HYDROCHLORIDE
17 2OXYCODONE HYDROCHLORIDE
18 4PROMETHAZINE HYDROCHLORIDE
19 1PROPYLTHIOURACIL
20 3TRIAMCINOLONE ACETONIDE
21 1VALPROIC ACID
01 2CAPSULE;ORAL
02 1GEL;TOPICAL
03 5GEL;TRANSDERMAL
04 4INJECTABLE;INJECTION
05 2LOTION;TOPICAL
06 1OIL/DROPS;OTIC
07 2OIL;TOPICAL
08 2OINTMENT;TOPICAL
09 1PASTE;DENTAL
10 6SOLUTION;ORAL
11 1SOLUTION;TOPICAL
12 6SYRUP;ORAL
13 12TABLET;ORAL
01 30.01%
02 10.025%
03 20.05%
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 1100MG
11 1100MG/5ML
12 2100MG/ML
13 110MG/5ML
14 110MG/5ML;6.25MG/5ML
15 112.5MG
16 11MG
17 1250MG/5ML
18 125MG
19 125MG/ML
20 12MG
21 12MG/5ML
22 1300MG;50MG
23 1300MG;50MG;40MG
24 1325MG;50MG
25 2325MG;50MG;40MG
26 14MG
27 15%
28 250MG
29 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
30 150MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
31 150MG/ML
32 35MG/5ML
33 16.25MG/5ML
34 175MG/ML
35 1EQ 1% BASE
36 1EQ 2MG BASE/5ML
01 7DISCN
02 1OTC
03 37RX
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 :
Dosage Form : SOLUTION; ORAL
Proprietary Name : CHILDRENS CETIRIZINE HYD...
Dosage Strength : 5MG/5ML
Approval Date : 2019-05-16
Application Number : 212266
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code : AB1
Dosage Form : GEL; TOPICAL
Proprietary Name : CLINDAMYCIN PHOSPHATE
Dosage Strength : EQ 1% BASE
Approval Date : 2020-07-29
Application Number : 211872
RX/OTC/DISCN : RX
RLD : No
TE Code : AB1
RLD : No
TE Code : AT
Dosage Form : SOLUTION; TOPICAL
Proprietary Name : CLOBETASOL PROPIONATE
Dosage Strength : 0.05%
Approval Date : 2022-02-17
Application Number : 211240
RX/OTC/DISCN : RX
RLD : No
TE Code : AT
RLD : No
TE Code : AA
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Dosage Form : SYRUP; ORAL
Proprietary Name : PROMETHAZINE HYDROCHLORI...
Dosage Strength : 10MG/5ML;6.25MG/5ML
Approval Date : 2020-10-08
Application Number : 214238
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
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