Somerset Pharmaceuticals Inc
FDA Approved Drugs

Somerset Pharmaceuticals Inc

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 OTC
  • Total Records 29
  • Latest Approval Date Dec 18, 2024
  • Data Source FDA
  • First Approval Date Feb 27, 2006
All
29
View
Unclassified
3
View
OTC
1
View
RX
25
View
Company Overview

Company

Somerset Pharmaceuticals Inc

Country

U.S.A

Website

Visit Website

Email

mlg@somersetpharm.com

Social Profiles

Company Snapshot

Somerset Pharmaceuticals Inc

5215 W. Laurel St. Tampa, FL 33607

U.S.A

www.somersetpharm.com/ mlg@somersetpharm.com View on Map
FDA Approved Drug Records ( 29 records )
2024
29 Apr
RX Application: 217791

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2024-04-29

217791 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

217791

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2024-04-29

Regulatory Status

RX

2024
10 Sep
RX Application: 216114

Drug Name

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2024-09-10

216114 / 1

Active Ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Application Number

216114

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2024-09-10

Regulatory Status

RX

2023
20 Nov
RX Application: 217792

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2023-11-20

217792 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

217792

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2023-11-20

Regulatory Status

RX

2023
20 Nov
RX Application: 217792

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2023-11-20

217792 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

217792

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2023-11-20

Regulatory Status

RX

2024
17 Dec
RX Application: 218133

Drug Name

CALCIUM CHLORIDE 10%

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2024-12-17

218133 / 1

Active Ingredient

CALCIUM CHLORIDE

Application Number

218133

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2024-12-17

Regulatory Status

RX

2023
19 Oct
RX Application: 217689

Drug Name

CALCIUM GLUCONATE

Product Number

1

Dosage Form

-

Strength

5GM/50ML (100MG/ML)

Approval Date

2023-10-19

217689 / 1

Active Ingredient

CALCIUM GLUCONATE

Application Number

217689

Product Number

1

Dosage Form

-

Strength

5GM/50ML (100MG/ML)

Approval Date

2023-10-19

Regulatory Status

RX

2023
19 Oct
RX Application: 217689

Drug Name

CALCIUM GLUCONATE

Product Number

2

Dosage Form

-

Strength

10GM/100ML (100MG/ML)

Approval Date

2023-10-19

217689 / 2

Active Ingredient

CALCIUM GLUCONATE

Application Number

217689

Product Number

2

Dosage Form

-

Strength

10GM/100ML (100MG/ML)

Approval Date

2023-10-19

Regulatory Status

RX

2019
24 Apr
RX Application: 209132

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2019-04-24

209132 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

209132

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2019-04-24

Regulatory Status

RX

2024
30 Apr
RX Application: 216113

Drug Name

CUPRIC CHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

2024-04-30

216113 / 1

Active Ingredient

CUPRIC CHLORIDE

Application Number

216113

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

2024-04-30

Regulatory Status

RX

2018
08 Jun
RX Application: 207521

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2018-06-08

207521 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

207521

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2018-06-08

Regulatory Status

RX

2024
24 Sep
RX Application: 218112

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

Approval Date

2024-09-24

218112 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

218112

Product Number

1

Dosage Form

-

Strength

EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

Approval Date

2024-09-24

Regulatory Status

RX

2024
24 Sep
RX Application: 218112

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

Approval Date

2024-09-24

218112 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

218112

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

Approval Date

2024-09-24

Regulatory Status

RX

2019
25 Jun
RX Application: 207523

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2019-06-25

207523 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

207523

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2019-06-25

Regulatory Status

RX

2006
27 Feb
RX Application: 21336

Drug Name

EMSAM

Product Number

1

Dosage Form

-

Strength

6MG/24HR

Approval Date

2006-02-27

21336 / 1

Active Ingredient

SELEGILINE

Application Number

21336

Product Number

1

Dosage Form

-

Strength

6MG/24HR

Approval Date

2006-02-27

Regulatory Status

RX

2006
27 Feb
RX Application: 21336

Drug Name

EMSAM

Product Number

2

Dosage Form

-

Strength

9MG/24HR

Approval Date

2006-02-27

21336 / 2

Active Ingredient

SELEGILINE

Application Number

21336

Product Number

2

Dosage Form

-

Strength

9MG/24HR

Approval Date

2006-02-27

Regulatory Status

RX

2006
27 Feb
RX Application: 21336

Drug Name

EMSAM

Product Number

3

Dosage Form

-

Strength

12MG/24HR

Approval Date

2006-02-27

21336 / 3

Active Ingredient

SELEGILINE

Application Number

21336

Product Number

3

Dosage Form

-

Strength

12MG/24HR

Approval Date

2006-02-27

Regulatory Status

RX

-
Unclassified Application: 21708

Drug Name

EMSAM

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

21708 / 1

Active Ingredient

SELEGILINE

Application Number

21708

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21708

Drug Name

EMSAM

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

-

21708 / 2

Active Ingredient

SELEGILINE

Application Number

21708

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21708

Drug Name

EMSAM

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

-

21708 / 3

Active Ingredient

SELEGILINE

Application Number

21708

Product Number

3

Dosage Form

-

Strength

12MG

Approval Date

-

Regulatory Status

Unclassified

2011
22 Mar
RX Application: 201786

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

201786 / 1

Active Ingredient

LATANOPROST

Application Number

201786

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

Regulatory Status

RX

2024
01 Aug
RX Application: 213597

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2024-08-01

213597 / 1

Active Ingredient

OFLOXACIN

Application Number

213597

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2024-08-01

Regulatory Status

RX

2024
18 Dec
OTC Application: 215006

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2024-12-18

215006 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

215006

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2024-12-18

Regulatory Status

OTC

2019
26 Jun
RX Application: 212231

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

2019-06-26

212231 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

212231

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

2019-06-26

Regulatory Status

RX

2024
10 Oct
RX Application: 216654

Drug Name

TIMOLOL

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2024-10-10

216654 / 1

Active Ingredient

TIMOLOL

Application Number

216654

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2024-10-10

Regulatory Status

RX

2024
03 Jul
RX Application: 217764

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2024-07-03

217764 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

217764

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2024-07-03

Regulatory Status

RX

2024
03 Jul
RX Application: 217764

Drug Name

TIMOLOL MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2024-07-03

217764 / 2

Active Ingredient

TIMOLOL MALEATE

Application Number

217764

Product Number

2

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2024-07-03

Regulatory Status

RX

2018
18 Jun
RX Application: 211035

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

2018-06-18

211035 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

211035

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

2018-06-18

Regulatory Status

RX

2018
18 Jun
RX Application: 211035

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

2018-06-18

211035 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

211035

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

2018-06-18

Regulatory Status

RX

2024
16 Oct
RX Application: 216152

Drug Name

ZINC CHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG ZINC/ML

Approval Date

2024-10-16

216152 / 1

Active Ingredient

ZINC CHLORIDE

Application Number

216152

Product Number

1

Dosage Form

-

Strength

EQ 1MG ZINC/ML

Approval Date

2024-10-16

Regulatory Status

RX

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Drug Status Breakdown
29 total
  • RX
  • Unclassified
  • OTC
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

ATROPINE SULFATE

Application Number

217791

Product Number

1

Active Ingredient

ATROPINE SULFATE

Dosage Form

-

Strength

1%

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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