Mikart RX
FDA Approved Drugs

Mikart RX

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX
  • Total Records 11
  • Latest Approval Date Jun 12, 2023
  • Data Source FDA
  • First Approval Date Jan 21, 1987
All
48
View
Discontinued
37
View
RX
11
View
Company Overview

Company

Mikart RX

Country

U.S.A

Website

Visit Website

Email

bizdev@mikart.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Mikart RX

1750 Chattahoochee Ave. Atlanta, GA 30318

U.S.A

www.mikart.com/ bizdev@mikart.com View on Map
FDA Approved Drug Records ( 11 records )
1987
21 Jan
RX Application: 89175

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1987-01-21

89175 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

89175

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1987-01-21

Regulatory Status

RX

1992
26 Oct
RX Application: 89987

Drug Name

BUTAPAP

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

1992-10-26

89987 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

89987

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

1992-10-26

Regulatory Status

RX

2016
31 May
RX Application: 207484

Drug Name

CARBINOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2016-05-31

207484 / 1

Active Ingredient

CARBINOXAMINE MALEATE

Application Number

207484

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2016-05-31

Regulatory Status

RX

2005
16 Sep
RX Application: 40590

Drug Name

ERGOTAMINE TARTRATE AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

2005-09-16

40590 / 1

Active Ingredient

CAFFEINE; ERGOTAMINE TARTRATE

Application Number

40590

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

2005-09-16

Regulatory Status

RX

2010
25 Feb
RX Application: 40881

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG/15ML;10MG/15ML

Approval Date

2010-02-25

40881 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40881

Product Number

1

Dosage Form

-

Strength

300MG/15ML;10MG/15ML

Approval Date

2010-02-25

Regulatory Status

RX

2023
12 Jun
RX Application: 212707

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-06-12

212707 / 1

Active Ingredient

METHOCARBAMOL

Application Number

212707

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2023-06-12

Regulatory Status

RX

2005
30 Dec
RX Application: 40608

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;2.5MG

Approval Date

2005-12-30

40608 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40608

Product Number

1

Dosage Form

-

Strength

300MG;2.5MG

Approval Date

2005-12-30

Regulatory Status

RX

2005
30 Dec
RX Application: 40608

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;5MG

Approval Date

2005-12-30

40608 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40608

Product Number

2

Dosage Form

-

Strength

300MG;5MG

Approval Date

2005-12-30

Regulatory Status

RX

2005
30 Dec
RX Application: 40608

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2005-12-30

40608 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40608

Product Number

3

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2005-12-30

Regulatory Status

RX

2005
30 Dec
RX Application: 40608

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

300MG;10MG

Approval Date

2005-12-30

40608 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40608

Product Number

4

Dosage Form

-

Strength

300MG;10MG

Approval Date

2005-12-30

Regulatory Status

RX

2018
27 Nov
RX Application: 202142

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG/5ML;10MG/5ML

Approval Date

2018-11-27

202142 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

202142

Product Number

1

Dosage Form

-

Strength

300MG/5ML;10MG/5ML

Approval Date

2018-11-27

Regulatory Status

RX

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    48 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
11 total
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Application Number

89175

Product Number

1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Dosage Form

-

Strength

325MG;50MG;40MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit