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

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01 13GRANULES

02 7ACCORD HLTHCARE

03 17ACTAVIS ELIZABETH

04 7ALKEM LABS LTD

05 7ALVOGEN

06 6ANI PHARMS

07 13ASCENT PHARMS INC

08 13AUROLIFE PHARMA LLC

09 7BARR

10 6BARR LABS INC

11 5CEDIPROF INC

12 6COREPHARMA

13 13ELITE LABS INC

14 6ENDO OPERATIONS

15 7EPIC PHARMA LLC

16 6IMPAX LABS

17 13LANNETT CO INC

18 6NESHER PHARMS

19 7NORVIUM BIOSCIENCE

20 7NUVO PHARM

21 13RHODES PHARMS

22 4SANDOZ

23 17SPECGX LLC

24 4SUN PHARM INDS INC

25 13SUN PHARM INDUSTRIES

26 10TAKEDA PHARMS USA

27 6TEVA

28 4TEVA PHARMS

29 4TEVA PHARMS USA

30 7TEVA WOMENS

31 6USPHARMA WINDLAS

32 7ZYDUS PHARMS

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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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG

Approval Date : 2021-12-28

Application Number : 215771

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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1.875MG;1.875MG;1.875MG;1.875MG

Approval Date : 2021-12-28

Application Number : 215771

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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG

Approval Date : 2021-12-28

Application Number : 215771

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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 3.125MG;3.125MG;3.125MG;3.125MG

Approval Date : 2021-12-28

Application Number : 215771

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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG

Approval Date : 2021-12-28

Application Number : 215771

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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;5MG;5MG;5MG

Approval Date : 2021-12-28

Application Number : 215771

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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5MG

Approval Date : 2021-12-28

Application Number : 215771

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 : AB1

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG

Approval Date : 2023-01-23

Application Number : 217027

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Granules India

09

  • 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 : AB1

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG

Approval Date : 2023-01-23

Application Number : 217027

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Granules India

10

  • 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 : AB1

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG

Approval Date : 2023-01-23

Application Number : 217027

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Granules India