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Approved Drug Products of Mikart listed in the FDA Orange Book. Original Data : FDA Website

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01 3ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

02 3ACETAMINOPHEN; BUTALBITAL

03 5ACETAMINOPHEN; BUTALBITAL; CAFFEINE

04 2ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

05 4ACETAMINOPHEN; CODEINE PHOSPHATE

06 17ACETAMINOPHEN; HYDROCODONE BITARTRATE

07 10ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

08 3BENZONATATE

09 1CAFFEINE; ERGOTAMINE TARTRATE

10 1CARBINOXAMINE MALEATE

11 3CHLORZOXAZONE

12 1ETHOSUXIMIDE

13 2METHAZOLAMIDE

14 1METHOCARBAMOL

15 1TRIHEXYPHENIDYL HYDROCHLORIDE

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01

Brand Name : ACETAMINOPHEN, ASPIR...

Mikart

Dosage Form : CAPSULE; ORAL

Proprietary Name : ACETAMINOPHEN, ASPIRIN, ...

Dosage Strength : 150MG;180MG;15MG

Approval Date : 1990-10-26

Application Number : 81095

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

02

Brand Name : ACETAMINOPHEN, ASPIR...

Mikart

Dosage Form : CAPSULE; ORAL

Proprietary Name : ACETAMINOPHEN, ASPIRIN, ...

Dosage Strength : 150MG;180MG;30MG

Approval Date : 1990-10-26

Application Number : 81096

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

03

Brand Name : ACETAMINOPHEN, ASPIR...

Mikart

Dosage Form : CAPSULE; ORAL

Proprietary Name : ACETAMINOPHEN, ASPIRIN, ...

Dosage Strength : 150MG;180MG;60MG

Approval Date : 1990-10-26

Application Number : 81097

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

04

Brand Name : BUTAPAP

Mikart

Dosage Form : TABLET; ORAL

Proprietary Name : BUTAPAP

Dosage Strength : 325MG;50MG

Approval Date : 1992-10-26

Application Number : 89987

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Mikart

05

Brand Name : BUTAPAP

Mikart

Dosage Form : TABLET; ORAL

Proprietary Name : BUTAPAP

Dosage Strength : 650MG;50MG

Approval Date : 1992-10-26

Application Number : 89988

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

06

Brand Name : BUTALBITAL AND ACETA...

Mikart

Dosage Form : TABLET; ORAL

Proprietary Name : BUTALBITAL AND ACETAMINO...

Dosage Strength : 300MG;50MG

Approval Date : 2016-11-15

Application Number : 207386

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Mikart

07

Brand Name : BUTALBITAL, ACETAMIN...

Mikart

Dosage Form : SOLUTION; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 325MG/15ML;50MG/15ML;40M...

Approval Date : 2003-01-31

Application Number : 40387

RX/OTC/DISCN : RX

RLD : No

TE Code :

Mikart

08

Brand Name : BUTALBITAL, ACETAMIN...

Mikart

Dosage Form : TABLET; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 750MG;50MG;40MG

Approval Date : 2003-12-23

Application Number : 40496

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart

09

Brand Name : BUTALBITAL, ACETAMIN...

Mikart

Dosage Form : TABLET; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 325MG;50MG;40MG

Approval Date : 1987-01-21

Application Number : 89175

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Mikart

10

Brand Name : ESGIC-PLUS

Mikart

Dosage Form : TABLET; ORAL

Proprietary Name : ESGIC-PLUS

Dosage Strength : 500MG;50MG;40MG

Approval Date : 1988-05-23

Application Number : 89451

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Mikart