Tris Pharma Inc
FDA Approved Drugs

Tris Pharma 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.

Discontinued RX OTC
  • Total Records 45
  • Latest Approval Date Jun 27, 2025
  • Data Source FDA
  • First Approval Date Aug 31, 2009
All
45
View
Discontinued
20
View
OTC
2
View
RX
23
View
Company Overview

Company

Tris Pharma Inc

Country

U.S.A

Website

Visit Website

Email

Info@trispharma.com

Social Profiles

Company Snapshot

Tris Pharma Inc

Brunswick Business Park, 2033 Route 130, Suite D, Monmouth Junction, NJ 08852,

U.S.A

www.trispharma.com/ Info@trispharma.com View on Map
FDA Approved Drug Records ( 45 records )
2012
16 Nov
Discontinued Application: 90572

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2012-11-16

90572 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90572

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2012-11-16

Regulatory Status

Discontinued

2012
16 Nov
Discontinued Application: 90572

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2012-11-16

90572 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90572

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2012-11-16

Regulatory Status

Discontinued

2009
03 Dec
Discontinued Application: 22499

Drug Name

CLONIDINE

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/ML

Approval Date

2009-12-03

22499 / 1

Active Ingredient

CLONIDINE

Application Number

22499

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/ML

Approval Date

2009-12-03

Regulatory Status

Discontinued

2021
21 Dec
Discontinued Application: 205431

Drug Name

CYPROHEPTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

2021-12-21

205431 / 1

Active Ingredient

CYPROHEPTADINE HYDROCHLORIDE

Application Number

205431

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

2021-12-21

Regulatory Status

Discontinued

2024
25 Apr
RX Application: 217813

Drug Name

DEFLAZACORT

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2024-04-25

217813 / 1

Active Ingredient

DEFLAZACORT

Application Number

217813

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2024-04-25

Regulatory Status

RX

2016
26 Aug
RX Application: 207901

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-08-26

207901 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

207901

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-08-26

Regulatory Status

RX

2016
26 Aug
RX Application: 207901

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-08-26

207901 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

207901

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-08-26

Regulatory Status

RX

2016
26 Aug
RX Application: 207901

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-08-26

207901 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

207901

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-08-26

Regulatory Status

RX

2013
29 May
RX Application: 203644

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2013-05-29

203644 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

203644

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2013-05-29

Regulatory Status

RX

2022
18 Aug
Discontinued Application: 206095

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-08-18

206095 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

206095

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-08-18

Regulatory Status

Discontinued

2022
18 Aug
Discontinued Application: 206095

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-08-18

206095 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

206095

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-08-18

Regulatory Status

Discontinued

2012
25 May
OTC Application: 91135

Drug Name

DEXTROMETHORPHAN POLISTIREX

Product Number

1

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

Approval Date

2012-05-25

91135 / 1

Active Ingredient

DEXTROMETHORPHAN POLISTIREX

Application Number

91135

Product Number

1

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

Approval Date

2012-05-25

Regulatory Status

OTC

2015
19 Oct
RX Application: 208147

Drug Name

DYANAVEL XR

Product Number

1

Dosage Form

-

Strength

2MG/ML;EQ 0.5MG BASE/ML

Approval Date

2015-10-19

208147 / 1

Active Ingredient

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Application Number

208147

Product Number

1

Dosage Form

-

Strength

2MG/ML;EQ 0.5MG BASE/ML

Approval Date

2015-10-19

Regulatory Status

RX

2021
04 Nov
RX Application: 210526

Drug Name

DYANAVEL XR 10

Product Number

2

Dosage Form

-

Strength

8MG;EQ 2MG BASE

Approval Date

2021-11-04

210526 / 2

Active Ingredient

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Application Number

210526

Product Number

2

Dosage Form

-

Strength

8MG;EQ 2MG BASE

Approval Date

2021-11-04

Regulatory Status

RX

2021
04 Nov
RX Application: 210526

Drug Name

DYANAVEL XR 15

Product Number

3

Dosage Form

-

Strength

12MG;EQ 3MG BASE

Approval Date

2021-11-04

210526 / 3

Active Ingredient

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Application Number

210526

Product Number

3

Dosage Form

-

Strength

12MG;EQ 3MG BASE

Approval Date

2021-11-04

Regulatory Status

RX

2021
04 Nov
RX Application: 210526

Drug Name

DYANAVEL XR 20

Product Number

4

Dosage Form

-

Strength

16MG;EQ 4MG BASE

Approval Date

2021-11-04

210526 / 4

Active Ingredient

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Application Number

210526

Product Number

4

Dosage Form

-

Strength

16MG;EQ 4MG BASE

Approval Date

2021-11-04

Regulatory Status

RX

2021
04 Nov
RX Application: 210526

Drug Name

DYANAVEL XR 5

Product Number

1

Dosage Form

-

Strength

4MG;EQ 1MG BASE

Approval Date

2021-11-04

210526 / 1

Active Ingredient

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Application Number

210526

Product Number

1

Dosage Form

-

Strength

4MG;EQ 1MG BASE

Approval Date

2021-11-04

Regulatory Status

RX

2025
27 Jun
Discontinued Application: 219454

Drug Name

GANIRELIX ACETATE

Product Number

1

Dosage Form

-

Strength

250MCG/0.5ML

Approval Date

2025-06-27

219454 / 1

Active Ingredient

GANIRELIX ACETATE

Application Number

219454

Product Number

1

Dosage Form

-

Strength

250MCG/0.5ML

Approval Date

2025-06-27

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 201295

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

2021-12-30

201295 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

201295

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

2021-12-30

Regulatory Status

Discontinued

2021
30 Dec
Discontinued Application: 201295

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG/15ML;10MG/15ML

Approval Date

2021-12-30

201295 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

201295

Product Number

2

Dosage Form

-

Strength

300MG/15ML;10MG/15ML

Approval Date

2021-12-30

Regulatory Status

Discontinued

2013
27 Mar
RX Application: 202214

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2013-03-27

202214 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202214

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2013-03-27

Regulatory Status

RX

2013
27 Mar
RX Application: 202214

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2013-03-27

202214 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202214

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2013-03-27

Regulatory Status

RX

2013
27 Mar
RX Application: 202214

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2013-03-27

202214 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202214

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2013-03-27

Regulatory Status

RX

2016
15 Mar
RX Application: 202214

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

300MG;5MG

Approval Date

2016-03-15

202214 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202214

Product Number

4

Dosage Form

-

Strength

300MG;5MG

Approval Date

2016-03-15

Regulatory Status

RX

2016
15 Mar
RX Application: 202214

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

5

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2016-03-15

202214 / 5

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202214

Product Number

5

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2016-03-15

Regulatory Status

RX

2016
15 Mar
RX Application: 202214

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

6

Dosage Form

-

Strength

300MG;10MG

Approval Date

2016-03-15

202214 / 6

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202214

Product Number

6

Dosage Form

-

Strength

300MG;10MG

Approval Date

2016-03-15

Regulatory Status

RX

2015
27 Jan
Discontinued Application: 206438

Drug Name

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG/5ML;5MG/5ML

Approval Date

2015-01-27

206438 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE

Application Number

206438

Product Number

1

Dosage Form

-

Strength

4MG/5ML;5MG/5ML

Approval Date

2015-01-27

Regulatory Status

Discontinued

2014
28 Oct
Discontinued Application: 203839

Drug Name

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML;60MG/5ML

Approval Date

2014-10-28

203839 / 1

Active Ingredient

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

203839

Product Number

1

Dosage Form

-

Strength

5MG/5ML;60MG/5ML

Approval Date

2014-10-28

Regulatory Status

Discontinued

2014
26 Nov
Discontinued Application: 203838

Drug Name

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4MG/5ML;5MG/5ML;60MG/5ML

Approval Date

2014-11-26

203838 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

203838

Product Number

1

Dosage Form

-

Strength

4MG/5ML;5MG/5ML;60MG/5ML

Approval Date

2014-11-26

Regulatory Status

Discontinued

2010
01 Oct
RX Application: 91632

Drug Name

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX

Product Number

1

Dosage Form

-

Strength

EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML

Approval Date

2010-10-01

91632 / 1

Active Ingredient

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

Application Number

91632

Product Number

1

Dosage Form

-

Strength

EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML

Approval Date

2010-10-01

Regulatory Status

RX

2009
31 Aug
OTC Application: 79058

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-08-31

79058 / 1

Active Ingredient

IBUPROFEN

Application Number

79058

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2009-08-31

Regulatory Status

OTC

2010
23 Jul
RX Application: 91601

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2010-07-23

91601 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

91601

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2010-07-23

Regulatory Status

RX

2010
23 Jul
RX Application: 91601

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2010-07-23

91601 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

91601

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2010-07-23

Regulatory Status

RX

2015
12 May
Discontinued Application: 203518

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2015-05-12

203518 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

203518

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2015-05-12

Regulatory Status

Discontinued

2015
12 May
RX Application: 203518

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2015-05-12

203518 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

203518

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2015-05-12

Regulatory Status

RX

2016
18 May
Discontinued Application: 203519

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

20MG/5ML

Approval Date

2016-05-18

203519 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

203519

Product Number

1

Dosage Form

-

Strength

20MG/5ML

Approval Date

2016-05-18

Regulatory Status

Discontinued

2024
24 May
RX Application: 217645

Drug Name

ONYDA XR

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

2024-05-24

217645 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

217645

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

2024-05-24

Regulatory Status

RX

2016
04 Mar
Discontinued Application: 201944

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-03-04

201944 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

201944

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2016-03-04

Regulatory Status

Discontinued

2016
04 Mar
Discontinued Application: 201944

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-03-04

201944 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

201944

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2016-03-04

Regulatory Status

Discontinued

2022
26 Jan
Discontinued Application: 214076

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2022-01-26

214076 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214076

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2022-01-26

Regulatory Status

Discontinued

2022
26 Jan
Discontinued Application: 214076

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2022-01-26

214076 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214076

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2022-01-26

Regulatory Status

Discontinued

2012
12 Dec
RX Application: 79059

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2012-12-12

79059 / 1

Active Ingredient

RISPERIDONE

Application Number

79059

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2012-12-12

Regulatory Status

RX

2021
17 Nov
Discontinued Application: 212312

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2021-11-17

212312 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

212312

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2021-11-17

Regulatory Status

Discontinued

2012
15 Jun
RX Application: 91586

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

2012-06-15

91586 / 1

Active Ingredient

THEOPHYLLINE

Application Number

91586

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

2012-06-15

Regulatory Status

RX

2015
30 Apr
Discontinued Application: 207768

Drug Name

TUZISTRA XR

Product Number

1

Dosage Form

-

Strength

EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML

Approval Date

2015-04-30

207768 / 1

Active Ingredient

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

Application Number

207768

Product Number

1

Dosage Form

-

Strength

EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML

Approval Date

2015-04-30

Regulatory Status

Discontinued

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Drug Status Breakdown
45 total
  • Discontinued
  • RX
  • 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

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

90572

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG/5ML

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

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