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PHARM ASSOC
FDA Orange Book

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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PHARM ASSOC

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 6 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
6 NEWS #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

68 FDF Dossiers, 68 FDA Orange Book

68 FDF Dossiers
68 FDA Orange Book

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filter Active Ingredients Reset all filters

68 All

01 3ACETAMINOPHEN; HYDROCODONE BITARTRATE

02 1AMANTADINE HYDROCHLORIDE

03 1BROMPHENIRAMINE MALEATE

04 1BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

05 3CETIRIZINE HYDROCHLORIDE

06 1CHLORHEXIDINE GLUCONATE

07 1CHLORPHENIRAMINE MALEATE

08 2CHLORPROMAZINE HYDROCHLORIDE

09 2CIMETIDINE HYDROCHLORIDE

10 1CITALOPRAM HYDROBROMIDE

11 2CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

12 1CYCLOSPORINE

13 1CYPROHEPTADINE HYDROCHLORIDE

14 1DIPHENHYDRAMINE HYDROCHLORIDE

15 1DOXEPIN HYDROCHLORIDE

16 1ETHOSUXIMIDE

17 1FLUOXETINE HYDROCHLORIDE

18 2FLUPHENAZINE HYDROCHLORIDE

19 1HALOPERIDOL LACTATE

20 2HYDROCORTISONE

21 1LACTULOSE

22 1LEVETIRACETAM

23 2LORATADINE

24 1LORAZEPAM

25 1MIDAZOLAM HYDROCHLORIDE

26 2MORPHINE SULFATE

27 1NORTRIPTYLINE HYDROCHLORIDE

28 1NYSTATIN

29 1ONDANSETRON HYDROCHLORIDE

30 2OXYBUTYNIN CHLORIDE

31 2OXYCODONE HYDROCHLORIDE

32 1PERPHENAZINE

33 2POTASSIUM CHLORIDE

34 3PREDNISOLONE

35 5PREDNISOLONE SODIUM PHOSPHATE

36 2PROMETHAZINE HYDROCHLORIDE

37 1RANITIDINE HYDROCHLORIDE

38 1RISPERIDONE

39 2SULFAMETHOXAZOLE; TRIMETHOPRIM

40 2THEOPHYLLINE

41 2THIORIDAZINE HYDROCHLORIDE

42 1TRIHEXYPHENIDYL HYDROCHLORIDE

43 1TRIPROLIDINE HYDROCHLORIDE

44 1VALPROIC ACID

filter Dosage Reset all filters

68 All

01 9CONCENTRATE;ORAL

02 1CREAM;TOPICAL

03 5ELIXIR;ORAL

04 1LOTION;TOPICAL

05 1SOLUTION, ELIXIR;ORAL

06 1SOLUTION;DENTAL

07 27SOLUTION;ORAL

08 3SUSPENSION;ORAL

09 1SYRUP; ORAL

10 19SYRUP;ORAL

filter Dosage Strength Reset all filters

68 All

01 10.12%

02 20.5%

03 11.25MG/5ML

04 1100,000 UNITS/ML

05 2100MG/5ML

06 4100MG/ML

07 110GM/15ML

08 110MG/5ML

09 210MG/5ML;6.25MG/5ML

10 112.5MG/5ML

11 215MG/5ML

12 116MG/5ML

13 21MG/ML

14 12.5MG/5ML

15 2200MG/5ML;40MG/5ML

16 120MEQ/15ML

17 2250MG/5ML

18 42MG/5ML

19 12MG/5ML;10MG/5ML;30MG/5ML

20 12MG/ML

21 230MG/ML

22 1325MG/15ML;10MG/15ML

23 1325MG/15ML;7.5MG/15ML

24 140MEQ/15ML

25 1500MG/15ML;7.5MG/15ML

26 150MG/5ML

27 85MG/5ML

28 15MG/ML

29 26.25MG/5ML

30 280MG/15ML

31 3EQ 10MG BASE/5ML

32 1EQ 10MG BASE/ML

33 1EQ 15MG BASE/5ML

34 1EQ 15MG BASE/ML

35 2EQ 20MG BASE/5ML

36 2EQ 2MG BASE/ML

37 2EQ 300MG BASE/5ML

38 1EQ 30MG BASE/5ML

39 1EQ 4MG BASE/5ML

40 1EQ 5MG BASE/5ML

filter Regulatory Info Reset all filters

68 All

01 37DISCN

02 30RX

03 1Blank

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01

Brand Name : HYDROCODONE BITARTRA...

U.S.A

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Brand Name : HYDROCODONE BITARTRA...

U.S.A

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RLD : No

TE Code :

ACETAMINOPHEN; HYDROCODONE BITARTRATE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : HYDROCODONE BITARTRATE A...

Dosage Strength : 500MG/15ML;7.5MG/15ML

Approval Date : 1998-03-13

Application Number : 40182

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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02

Brand Name : HYDROCODONE BITARTRA...

U.S.A

PackExpo

Not Confirmed

Brand Name : HYDROCODONE BITARTRA...

U.S.A

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RLD : No

TE Code :

ACETAMINOPHEN; HYDROCODONE BITARTRATE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : HYDROCODONE BITARTRATE A...

Dosage Strength : 325MG/15ML;10MG/15ML

Approval Date : 2008-04-18

Application Number : 40834

RX/OTC/DISCN : RX

RLD : No

TE Code :

Product
Web Link

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#PipelineProspector

03

Brand Name : HYDROCODONE BITARTRA...

U.S.A

PackExpo

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Brand Name : HYDROCODONE BITARTRA...

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RLD : No

TE Code : AA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : HYDROCODONE BITARTRATE A...

Dosage Strength : 325MG/15ML;7.5MG/15ML

Approval Date : 2013-05-10

Application Number : 40838

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
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04

Brand Name : AMANTADINE HYDROCHLO...

U.S.A

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Brand Name : AMANTADINE HYDROCHLO...

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RLD : No

TE Code : AA

AMANTADINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SYRUP; ORAL

Proprietary Name : AMANTADINE HYDROCHLORIDE

Dosage Strength : 50MG/5ML

Approval Date : 1995-07-17

Application Number : 74509

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
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05

Brand Name : BROMPHENIRAMINE MALE...

U.S.A

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Brand Name : BROMPHENIRAMINE MALE...

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RLD : No

TE Code :

BROMPHENIRAMINE MALEATE

PHARM ASSOC

Dosage Form : ELIXIR; ORAL

Proprietary Name : BROMPHENIRAMINE MALEATE

Dosage Strength : 2MG/5ML

Approval Date : 1982-01-01

Application Number : 87517

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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06

Brand Name : BROMPHENIRAMINE MALE...

U.S.A

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RLD : No

TE Code : AA

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SYRUP; ORAL

Proprietary Name : BROMPHENIRAMINE MALEATE,...

Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5M...

Approval Date : 2014-07-21

Application Number : 202940

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
Web Link

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07

Brand Name : CETIRIZINE HYDROCHLO...

U.S.A

PackExpo

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Brand Name : CETIRIZINE HYDROCHLO...

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RLD : No

TE Code : AA

CETIRIZINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : CETIRIZINE HYDROCHLORIDE

Dosage Strength : 5MG/5ML

Approval Date : 2008-06-18

Application Number : 78412

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Product
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08

Brand Name : CHILDRENS CETIRIZINE...

U.S.A

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Brand Name : CHILDRENS CETIRIZINE...

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RLD : No

TE Code :

CETIRIZINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : CHILDRENS CETIRIZINE HYD...

Dosage Strength : 5MG/5ML

Approval Date : 2008-04-22

Application Number : 90188

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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09

Brand Name : CHILDRENS CETIRIZINE...

U.S.A

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Brand Name : CHILDRENS CETIRIZINE...

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RLD : No

TE Code :

CETIRIZINE HYDROCHLORIDE

PHARM ASSOC

Dosage Form : SOLUTION; ORAL

Proprietary Name : CHILDRENS CETIRIZINE HYD...

Dosage Strength : 5MG/5ML

Approval Date : 2008-04-22

Application Number : 90188

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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10

Brand Name : CHLORHEXIDINE GLUCON...

U.S.A

PackExpo

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Brand Name : CHLORHEXIDINE GLUCON...

U.S.A

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RLD : No

TE Code : AT

CHLORHEXIDINE GLUCONATE

PHARM ASSOC

Dosage Form : SOLUTION; DENTAL

Proprietary Name : CHLORHEXIDINE GLUCONATE

Dosage Strength : 0.12%

Approval Date : 1995-12-15

Application Number : 74522

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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