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Approved Drug Products containing Focalin listed in the FDA Orange Book. Original Data : FDA Website

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01 8GRANULES

02 3ABHAI INC

03 8ADARE PHARMS INC

04 3ALKEM LABS LTD

05 8ASCENT PHARMS INC

06 8AUROLIFE PHARMA LLC

07 2BIONPHARMA

08 2CEDIPROF INC

09 3COMMAVE THERAP

10 8ENDO OPERATIONS

11 7IMPAX LABS INC

12 6INTELLIPHARMACEUTICS

13 3LANNETT CO INC

14 3NOVEL LABS INC

15 3RHODES PHARMS

16 11SANDOZ

17 8SUN PHARM INDS INC

18 3SUN PHARM INDUSTRIES

19 3TEVA PHARMS

20 9TEVA PHARMS USA

21 3TRIS PHARMA INC

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 35MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Approval Date : 2020-09-09

Application Number : 213813

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

09

Pharmaconex 2024
Not Confirmed
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10

Pharmaconex 2024
Not Confirmed
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