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Approved Drug Products containing MolPort-002-163-732 listed in the FDA Orange Book. Original Data : FDA Website

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01 5STRIDES PHARMA

02 5ACCORD HLTHCARE

03 4AIPING PHARM INC

04 5AMNEAL PHARMS CO

05 5AUROBINDO PHARMA LTD

06 8BRISTOL MYERS SQUIBB

07 3EGIS

08 5EPIC PHARMA LLC

09 4HERITAGE PHARMA

10 3IMPAX LABS INC

11 5INVENTIA HLTHCARE

12 3IVAX SUB TEVA PHARMS

13 9MYLAN

14 3NESHER PHARMS

15 4OXFORD PHARMS

16 3RISING PHARMA

17 5RUBICON

18 4TEVA

19 4UNICHEM

20 5ZYDUS 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 : AB

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPIRONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2014-08-25

Application Number : 202330

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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 : AB

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPIRONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2014-08-25

Application Number : 202330

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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 : AB

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPIRONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date : 2014-08-25

Application Number : 202330

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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 : AB

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPIRONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date : 2014-08-25

Application Number : 202330

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

05

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPIRONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 7.5MG

Approval Date : 2017-02-17

Application Number : 202330

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPAR

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-09-29

Application Number : 18731

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPAR

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-09-29

Application Number : 18731

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPAR

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-04-22

Application Number : 18731

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPAR

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-04-22

Application Number : 18731

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

10

AAPS 2024
Not Confirmed
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arrow
AAPS 2024
Not Confirmed

BUSPIRONE HYDROCHLORIDE

Brand Name : BUSPAR

Dosage Form : CAPSULE;ORAL

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

Approval Date : 2000-12-20

Application Number : 21190

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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