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Approved Drug Products containing AH-3365 listed in the FDA Orange Book. Original Data : FDA Website

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01 4STRIDES PHARMA

02 2ACTAVIS MID ATLANTIC

03 2AIZANT

04 2AM THERAP

05 1AMNEAL PHARMS

06 2AMNEAL PHARMS CO

07 5APOTEX INC

08 2ARMSTRONG PHARMS

09 2AUROBINDO PHARMA LTD

10 2BAUSCH

11 2BOEHRINGER INGELHEIM

12 1CHARTWELL MOLECULAR

13 4CHARTWELL RX

14 2CIPLA

15 4COPLEY PHARM

16 1COSETTE

17 2DASH PHARMS NATCO

18 1EPIC PHARMA LLC

19 2EYWA

20 1FOSUN PHARMA

21 1GENPHARM

22 8GLAXOSMITHKLINE

23 1HIKMA

24 1IVAX SUB TEVA PHARMS

25 1KINDEVA

26 1LANDELA PHARM

27 2LEXENPHARM

28 4LUOXIN AUROVITAS

29 1LUPIN

30 1MOVA

31 2MURO

32 6NEPHRON

33 4NORVIUM BIOSCIENCE

34 1PADAGIS US

35 3PLIVA

36 1QUAGEN

37 2RISING

38 2RISING PHARMA

39 4RITEDOSE CORP

40 1ROXANE

41 1SANDOZ

42 7SCHERING

43 1SENTISS

44 2SUN PHARM

45 2SUN PHARM INDUSTRIES

46 7TEVA

47 3TEVA BRANDED PHARM

48 2TEVA PHARMS

49 2UCB INC

50 2VIRTUS PHARM

51 2WARNER CHILCOTT

52 7WATSON LABS

53 1WATSON LABS INC

54 1WATSON LABS TEVA

55 1WOCKHARDT EU OPERATN

56 2ZYDUS PHARMS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

ALBUTEROL SULFATE

Brand Name : ALBUTEROL SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 1989-12-20

Application Number : 72860

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

ALBUTEROL SULFATE

Brand Name : ALBUTEROL SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE

Approval Date : 1989-12-20

Application Number : 72860

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

ALBUTEROL SULFATE

Brand Name : VOSPIRE ER

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2002-09-26

Application Number : 76130

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

ALBUTEROL SULFATE

Brand Name : VOSPIRE ER

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 8MG BASE

Approval Date : 2002-09-26

Application Number : 76130

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ALBUTEROL

Brand Name : PROVENTIL

Dosage Form : AEROSOL, METERED;INHALATION

Dosage Strength : 0.09MG/INH

Approval Date : 1982-01-01

Application Number : 17559

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ALBUTEROL SULFATE

Brand Name : PROVENTIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-05-07

Application Number : 17853

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ALBUTEROL SULFATE

Brand Name : PROVENTIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-05-07

Application Number : 17853

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ALBUTEROL SULFATE

Brand Name : PROVENTIL

Dosage Form : SYRUP;ORAL

Dosage Strength : EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1983-01-19

Application Number : 18062

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ALBUTEROL

Brand Name : VENTOLIN

Dosage Form : AEROSOL, METERED;INHALATION

Dosage Strength : 0.09MG/INH

Approval Date : 1982-01-01

Application Number : 18473

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

10

AAPS 2024
Not Confirmed
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arrow
AAPS 2024
Not Confirmed

ALBUTEROL SULFATE

Brand Name : VENTOLIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE

Approval Date : 1986-07-10

Application Number : 19112

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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