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Approved Drug Products containing Prestwick3_000518 listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS LABS SA

02 1ACTAVIS LABS FL INC

03 1AMNEAL PHARMS

04 2APOTEX INC

05 8ASTRAZENECA

06 1ASTRAZENECA AB

07 1AUROBINDO PHARMA USA

08 1BARR LABS DIV TEVA

09 1CALLIDITAS

10 2CHEPLAPHARM

11 3CIPLA

12 1EUGIA PHARMA

13 2IMPAX LABS INC

14 3J AND J CONSUMER INC

15 1LUPIN

16 3MYLAN

17 1NATCO

18 2NEPHRON

19 1PADAGIS ISRAEL

20 1PADAGIS US

21 1RISING PHARMA

22 2SALIX

23 3SANDOZ

24 1SCIECURE PHARMA INC

25 3SUN PHARM

26 2SUN PHARM INDS INC

27 1TAKEDA PHARMS USA

28 2TEVA PHARMS

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30 1ZYDUS PHARMS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

BUDESONIDE

Brand Name : BUDESONIDE

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : 3MG

Approval Date : 2016-04-08

Application Number : 206623

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

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BUDESONIDE

Brand Name : RHINOCORT

Dosage Form : AEROSOL, METERED;NASAL

Dosage Strength : 0.032MG/INH

Approval Date : 1994-02-14

Application Number : 20233

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

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BUDESONIDE

Brand Name : PULMICORT

Dosage Form : POWDER, METERED;INHALATION

Dosage Strength : 0.16MG/INH

Approval Date : 1997-06-24

Application Number : 20441

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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BUDESONIDE

Brand Name : PULMICORT

Dosage Form : POWDER, METERED;INHALATION

Dosage Strength : 0.32MG/INH

Approval Date : 1997-06-24

Application Number : 20441

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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BUDESONIDE

Brand Name : PULMICORT RESPULES

Dosage Form : SUSPENSION;INHALATION

Dosage Strength : 0.25MG/2ML

Approval Date : 2000-08-08

Application Number : 20929

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AN

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06

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BUDESONIDE

Brand Name : PULMICORT RESPULES

Dosage Form : SUSPENSION;INHALATION

Dosage Strength : 0.5MG/2ML

Approval Date : 2000-08-08

Application Number : 20929

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AN

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07

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BUDESONIDE

Brand Name : PULMICORT RESPULES

Dosage Form : SUSPENSION;INHALATION

Dosage Strength : 1MG/2ML

Approval Date : 2000-08-08

Application Number : 20929

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AN

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08

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BUDESONIDE

Brand Name : RHINOCORT

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.032MG/INH

Approval Date :

Application Number : 20746

RX/OTC/DISCN :

RLD :

TE Code :

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09

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BUDESONIDE

Brand Name : RHINOCORT

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.064MG/INH

Approval Date :

Application Number : 20746

RX/OTC/DISCN :

RLD :

TE Code :

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10

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BUDESONIDE

Brand Name : RHINOCORT ALLERGY

Dosage Form : SPRAY, METERED;NASAL

Dosage Strength : 0.032MG/SPRAY

Approval Date : 2015-03-23

Application Number : 20746

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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