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Graviti Pharmaceuticals
FDA Orange Book

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pharmacompass-2-m-2025-08-25

Graviti Pharmaceuticals

VISIT THE VIRTUAL BOOTH, Contact Details

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 9 News #PharmaBuzz

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FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers, 71 FDA Orange Book

71 FDF Dossiers
71 FDA Orange Book

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71 All

01 1ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

02 2AMLODIPINE BESYLATE

03 4ATORVASTATIN CALCIUM

04 3BACLOFEN

05 2BUPROPION HYDROCHLORIDE

06 4CARVEDILOL

07 3CYCLOBENZAPRINE HYDROCHLORIDE

08 3ESCITALOPRAM OXALATE

09 3ESOMEPRAZOLE MAGNESIUM

10 2FAMOTIDINE

11 3FUROSEMIDE

12 3HYDROXYZINE HYDROCHLORIDE

13 3LORAZEPAM

14 2MELOXICAM

15 2PANTOPRAZOLE SODIUM

16 12QUETIAPINE FUMARATE

17 5SIMVASTATIN

18 3SPIRONOLACTONE

19 1TAMSULOSIN HYDROCHLORIDE

20 2TIZANIDINE HYDROCHLORIDE

21 2TRAMADOL HYDROCHLORIDE

22 4TRAZODONE HYDROCHLORIDE

23 2VALACYCLOVIR HYDROCHLORIDE

filter Dosage Reset all filters

71 All

01 2CAPSULE, DELAYED REL PELLETS;ORAL

02 1CAPSULE, DELAYED RELEASE;ORAL

03 1CAPSULE;ORAL

04 2TABLET, DELAYED RELEASE;ORAL

05 7TABLET, EXTENDED RELEASE;ORAL

06 58TABLET;ORAL

filter Dosage Strength Reset all filters

71 All

01 10.4MG

02 10.5MG

03 3100MG

04 510MG

05 112.5MG

06 2150MG

07 115MG

08 11MG

09 420MG

10 325MG

11 12MG

12 13.125MG

13 2300MG

14 1325MG;37.5MG

15 240MG

16 450MG

17 35MG

18 16.25MG

19 27.5MG

20 280MG

21 1EQ 100MG BASE

22 3EQ 10MG BASE

23 2EQ 150MG BASE

24 1EQ 1GM BASE

25 2EQ 200MG BASE

26 5EQ 20MG BASE

27 1EQ 25MG BASE

28 1EQ 2MG BASE

29 2EQ 300MG BASE

30 2EQ 400MG BASE

31 3EQ 40MG BASE

32 1EQ 4MG BASE

33 1EQ 500MG BASE

34 2EQ 50MG BASE

35 2EQ 5MG BASE

36 1EQ 80MG BASE

filter Regulatory Info Reset all filters

71 All

01 4DISCN

02 3OTC

03 64RX

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Brand Name : TRAMADOL HYDROCHLORI...

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Brand Name : TRAMADOL HYDROCHLORI...

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TE Code :

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : TRAMADOL HYDROCHLORIDE A...

Dosage Strength : 325MG;37.5MG

Approval Date : 2006-07-26

Application Number : 76914

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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#PipelineProspector

02

Brand Name : AMLODIPINE BESYLATE

Coatings Trends

Not Confirmed

Brand Name : AMLODIPINE BESYLATE

Coatings Trends

Not Confirmed

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RLD : No

TE Code :

AMLODIPINE BESYLATE

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : AMLODIPINE BESYLATE

Dosage Strength : EQ 5MG BASE

Approval Date : 2012-04-13

Application Number : 201380

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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03

Brand Name : AMLODIPINE BESYLATE

Coatings Trends

Not Confirmed

Brand Name : AMLODIPINE BESYLATE

Coatings Trends

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RLD : No

TE Code :

AMLODIPINE BESYLATE

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : AMLODIPINE BESYLATE

Dosage Strength : EQ 10MG BASE

Approval Date : 2012-04-13

Application Number : 201380

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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#PipelineProspector

04

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

Not Confirmed

Brand Name : ATORVASTATIN CALCIUM

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Digital Content

RLD : No

TE Code : AB

ATORVASTATIN CALCIUM

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : ATORVASTATIN CALCIUM

Dosage Strength : EQ 10MG BASE

Approval Date : 2018-06-18

Application Number : 209912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

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05

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

Not Confirmed

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

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Digital Content

RLD : No

TE Code : AB

ATORVASTATIN CALCIUM

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : ATORVASTATIN CALCIUM

Dosage Strength : EQ 20MG BASE

Approval Date : 2018-06-18

Application Number : 209912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

Not Confirmed

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

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Digital Content

RLD : No

TE Code : AB

ATORVASTATIN CALCIUM

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : ATORVASTATIN CALCIUM

Dosage Strength : EQ 40MG BASE

Approval Date : 2018-06-18

Application Number : 209912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

07

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

Not Confirmed

Brand Name : ATORVASTATIN CALCIUM

Coatings Trends

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

ATORVASTATIN CALCIUM

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : ATORVASTATIN CALCIUM

Dosage Strength : EQ 80MG BASE

Approval Date : 2018-06-18

Application Number : 209912

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

08

Brand Name : BACLOFEN

Coatings Trends

Not Confirmed

Brand Name : BACLOFEN

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Digital Content

RLD : No

TE Code : AB

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : BACLOFEN

Dosage Strength : 10MG

Approval Date : 2024-01-10

Application Number : 217788

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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09

Brand Name : BACLOFEN

Coatings Trends

Not Confirmed

Brand Name : BACLOFEN

Coatings Trends

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Digital Content

RLD : No

TE Code : AB

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : BACLOFEN

Dosage Strength : 20MG

Approval Date : 2024-01-10

Application Number : 217788

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
Web Link

Stock Recap
#PipelineProspector

10

Brand Name : BACLOFEN

Coatings Trends

Not Confirmed

Brand Name : BACLOFEN

Coatings Trends

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

Graviti Pharmaceuticals

Dosage Form : TABLET; ORAL

Proprietary Name : BACLOFEN

Dosage Strength : 5MG

Approval Date : 2024-10-24

Application Number : 217788

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product
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