Sigmapharm Laboratories, LLC
FDA Approved Drugs

Sigmapharm Laboratories, LLC

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 Unclassified Discontinued
  • Total Records 34
  • Latest Approval Date Dec 10, 2020
  • Data Source FDA
  • First Approval Date Jan 30, 2009
All
34
View
Unclassified
2
View
Discontinued
7
View
RX
25
View
Company Overview

Company

Sigmapharm Laboratories, LLC

Country

U.S.A

Website

Visit Website

Email

akotrotsios@sigmapharm.com

Social Profiles

Company Snapshot

Sigmapharm Laboratories, LLC

Sigmapharm Laboratories, LLC 3375 Progress Drive Bensalem

U.S.A

www.sigmapharm.com/ akotrotsios@sigmapharm.com View on Map
FDA Approved Drug Records ( 34 records )
2015
22 May
RX Application: 204633

Drug Name

ACITRETIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-05-22

204633 / 1

Active Ingredient

ACITRETIN

Application Number

204633

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-05-22

Regulatory Status

RX

2015
22 May
RX Application: 204633

Drug Name

ACITRETIN

Product Number

2

Dosage Form

-

Strength

17.5MG

Approval Date

2015-05-22

204633 / 2

Active Ingredient

ACITRETIN

Application Number

204633

Product Number

2

Dosage Form

-

Strength

17.5MG

Approval Date

2015-05-22

Regulatory Status

RX

2015
22 May
RX Application: 204633

Drug Name

ACITRETIN

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-05-22

204633 / 3

Active Ingredient

ACITRETIN

Application Number

204633

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2015-05-22

Regulatory Status

RX

2015
22 May
RX Application: 204633

Drug Name

ACITRETIN

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2015-05-22

204633 / 4

Active Ingredient

ACITRETIN

Application Number

204633

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2015-05-22

Regulatory Status

RX

2013
29 Aug
RX Application: 202051

Drug Name

ADEFOVIR DIPIVOXIL

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2013-08-29

202051 / 1

Active Ingredient

ADEFOVIR DIPIVOXIL

Application Number

202051

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2013-08-29

Regulatory Status

RX

2019
10 Apr
RX Application: 208354

Drug Name

AMBRISENTAN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-10

208354 / 1

Active Ingredient

AMBRISENTAN

Application Number

208354

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-10

Regulatory Status

RX

2019
10 Apr
RX Application: 208354

Drug Name

AMBRISENTAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-04-10

208354 / 2

Active Ingredient

AMBRISENTAN

Application Number

208354

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-04-10

Regulatory Status

RX

2009
30 Jan
RX Application: 79133

Drug Name

AMILORIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-01-30

79133 / 1

Active Ingredient

AMILORIDE HYDROCHLORIDE

Application Number

79133

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-01-30

Regulatory Status

RX

-
Unclassified Application: 210053

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

210053 / 1

Active Ingredient

APIXABAN

Application Number

210053

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 210053

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

210053 / 2

Active Ingredient

APIXABAN

Application Number

210053

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

2020
10 Dec
RX Application: 206107

Drug Name

ASENAPINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2020-12-10

206107 / 1

Active Ingredient

ASENAPINE MALEATE

Application Number

206107

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2020-12-10

Regulatory Status

RX

2020
10 Dec
RX Application: 206107

Drug Name

ASENAPINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-12-10

206107 / 2

Active Ingredient

ASENAPINE MALEATE

Application Number

206107

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-12-10

Regulatory Status

RX

2011
28 Mar
RX Application: 91619

Drug Name

DISULFIRAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-03-28

91619 / 1

Active Ingredient

DISULFIRAM

Application Number

91619

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-03-28

Regulatory Status

RX

2011
28 Mar
RX Application: 91619

Drug Name

DISULFIRAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-03-28

91619 / 2

Active Ingredient

DISULFIRAM

Application Number

91619

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-03-28

Regulatory Status

RX

2018
26 Mar
RX Application: 207746

Drug Name

DOFETILIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-03-26

207746 / 1

Active Ingredient

DOFETILIDE

Application Number

207746

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-03-26

Regulatory Status

RX

2018
26 Mar
RX Application: 207746

Drug Name

DOFETILIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-03-26

207746 / 2

Active Ingredient

DOFETILIDE

Application Number

207746

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-03-26

Regulatory Status

RX

2018
26 Mar
RX Application: 207746

Drug Name

DOFETILIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-03-26

207746 / 3

Active Ingredient

DOFETILIDE

Application Number

207746

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-03-26

Regulatory Status

RX

2010
14 Jul
Discontinued Application: 91004

Drug Name

ERGOCALCIFEROL

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

2010-07-14

91004 / 1

Active Ingredient

ERGOCALCIFEROL

Application Number

91004

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

2010-07-14

Regulatory Status

Discontinued

2011
28 Jun
RX Application: 201566

Drug Name

FLUCYTOSINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-28

201566 / 1

Active Ingredient

FLUCYTOSINE

Application Number

201566

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-06-28

Regulatory Status

RX

2011
28 Jun
RX Application: 201566

Drug Name

FLUCYTOSINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-28

201566 / 2

Active Ingredient

FLUCYTOSINE

Application Number

201566

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2011-06-28

Regulatory Status

RX

2012
22 Oct
RX Application: 202482

Drug Name

GRISEOFULVIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2012-10-22

202482 / 1

Active Ingredient

GRISEOFULVIN, MICROSIZE

Application Number

202482

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2012-10-22

Regulatory Status

RX

2012
22 Oct
RX Application: 202545

Drug Name

GRISEOFULVIN,ULTRAMICROSIZE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2012-10-22

202545 / 1

Active Ingredient

GRISEOFULVIN, ULTRAMICROSIZE

Application Number

202545

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2012-10-22

Regulatory Status

RX

2012
22 Oct
RX Application: 202545

Drug Name

GRISEOFULVIN,ULTRAMICROSIZE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2012-10-22

202545 / 2

Active Ingredient

GRISEOFULVIN, ULTRAMICROSIZE

Application Number

202545

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2012-10-22

Regulatory Status

RX

2012
29 Nov
RX Application: 200295

Drug Name

LIOTHYRONINE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2012-11-29

200295 / 1

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

200295

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2012-11-29

Regulatory Status

RX

2012
29 Nov
RX Application: 200295

Drug Name

LIOTHYRONINE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2012-11-29

200295 / 2

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

200295

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2012-11-29

Regulatory Status

RX

2012
29 Nov
RX Application: 200295

Drug Name

LIOTHYRONINE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2012-11-29

200295 / 3

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

200295

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2012-11-29

Regulatory Status

RX

2018
07 May
Discontinued Application: 207745

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2018-05-07

207745 / 1

Active Ingredient

NITROGLYCERIN

Application Number

207745

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2018-05-07

Regulatory Status

Discontinued

2018
07 May
Discontinued Application: 207745

Drug Name

NITROGLYCERIN

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2018-05-07

207745 / 2

Active Ingredient

NITROGLYCERIN

Application Number

207745

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2018-05-07

Regulatory Status

Discontinued

2018
07 May
Discontinued Application: 207745

Drug Name

NITROGLYCERIN

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2018-05-07

207745 / 3

Active Ingredient

NITROGLYCERIN

Application Number

207745

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2018-05-07

Regulatory Status

Discontinued

2016
19 Aug
Discontinued Application: 207528

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-08-19

207528 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

207528

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-08-19

Regulatory Status

Discontinued

2016
19 Aug
Discontinued Application: 207528

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-08-19

207528 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

207528

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-08-19

Regulatory Status

Discontinued

2010
03 May
RX Application: 90462

Drug Name

PROTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-05-03

90462 / 1

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

90462

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-05-03

Regulatory Status

RX

2010
03 May
RX Application: 90462

Drug Name

PROTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-05-03

90462 / 2

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

90462

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-05-03

Regulatory Status

RX

2013
22 Mar
Discontinued Application: 202819

Drug Name

SODIUM PHENYLBUTYRATE

Product Number

1

Dosage Form

-

Strength

3GM/TEASPOONFUL

Approval Date

2013-03-22

202819 / 1

Active Ingredient

SODIUM PHENYLBUTYRATE

Application Number

202819

Product Number

1

Dosage Form

-

Strength

3GM/TEASPOONFUL

Approval Date

2013-03-22

Regulatory Status

Discontinued

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Drug Status Breakdown
34 total
  • RX
  • Unclassified
  • Discontinued
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

ACITRETIN

Application Number

204633

Product Number

1

Active Ingredient

ACITRETIN

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Searchable pharmaceutical data

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