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

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01 3GRANULES

02 3ACCORD HLTHCARE

03 4ACI

04 2ALMATICA

05 3ANDA REPOSITORY

06 3APPCO

07 3ASCENT PHARMS INC

08 4AUROBINDO PHARMA

09 5CHARTWELL MOLECULAR

10 12HERITAGE PHARMA AVET

11 3HIKMA PHARMS

12 3INVAGEN PHARMS

13 3IVAX SUB TEVA PHARMS

14 3LUPIN

15 3MYLAN PHARMS INC

16 6NORVIUM BIOSCIENCE

17 3OXFORD PHARMS

18 1RANBAXY LABS LTD

19 3REYOUNG

20 3SCIEGEN PHARMS INC

21 3SUN PHARM INDS (IN)

22 5SUN PHARM INDS LTD

23 3TORRENT PHARMS

24 6VIATRIS

25 3VIWIT PHARM

26 3ZYDUS

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PharmaCompass

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

SERTRALINE HYDROCHLORIDE

Brand Name : SERTRALINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2008-01-08

Application Number : 78403

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

SERTRALINE HYDROCHLORIDE

Brand Name : SERTRALINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2008-01-08

Application Number : 78403

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

SERTRALINE HYDROCHLORIDE

Brand Name : SERTRALINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2008-01-08

Application Number : 78403

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

04

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SERTRALINE HYDROCHLORIDE

Brand Name : SERTRALINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2006-06-30

Application Number : 75719

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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SERTRALINE HYDROCHLORIDE

Brand Name : ZOLOFT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 1991-12-30

Application Number : 19839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

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SERTRALINE HYDROCHLORIDE

Brand Name : ZOLOFT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 1991-12-30

Application Number : 19839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

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SERTRALINE HYDROCHLORIDE

Brand Name : ZOLOFT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-12-30

Application Number : 19839

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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SERTRALINE HYDROCHLORIDE

Brand Name : ZOLOFT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-12-30

Application Number : 19839

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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SERTRALINE HYDROCHLORIDE

Brand Name : ZOLOFT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 1996-03-06

Application Number : 19839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

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SERTRALINE HYDROCHLORIDE

Brand Name : ZOLOFT

Dosage Form : CONCENTRATE;ORAL

Dosage Strength : EQ 20MG BASE/ML

Approval Date : 1999-12-07

Application Number : 20990

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AA

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