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Approved Drug Products containing Tox21_300269 listed in the FDA Orange Book. Original Data : FDA Website

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01 1STRIDES PHARMA

02 4ABIC

03 6ABRAXIS PHARM

04 5ACCORD HLTHCARE

05 1ALEMBIC

06 1AMNEAL PHARMS

07 1AZURITY

08 5BARR

09 4BRISTOL

10 1BRISTOL MYERS

11 1BRISTOL MYERS SQUIBB

12 1DAITO

13 1DURAMED PHARMS BARR

14 1ELITE LABS INC

15 1EUGIA PHARMA

16 4EUGIA PHARMA SPECLTS

17 1EXTROVIS

18 4FRESENIUS KABI USA

19 6HIKMA

20 12HOSPIRA

21 1LOTUS PHARM CO LTD

22 10MEDEXUS

23 1MYLAN

24 1NORBROOK

25 8NORDIC GRP

26 14OTTER PHARMS

27 4PHARMACHEMIE BV

28 1PHARMACHEMIE USA

29 6PHARMACIA AND UPJOHN

30 6QUAD PHARMS

31 3SAGENT PHARMS INC

32 3SANDOZ

33 4SHORLA

34 1SUN PHARM

35 1ZYDUS PHARMS

36 3Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

RLD : Yes

TE Code :

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 8085

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Strides Pharma Science

02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 20MG BASE/VIAL

Approval Date : 1982-01-01

Application Number : 11719

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/VIAL

Approval Date : 1982-01-01

Application Number : 11719

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 2.5MG BASE/ML

Approval Date : 1982-01-01

Application Number : 11719

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 25MG BASE/ML

Approval Date : 1982-01-01

Application Number : 11719

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 100MG BASE/VIAL

Approval Date : 1982-01-01

Application Number : 11719

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

METHOTREXATE SODIUM

Brand Name : METHOTREXATE LPF

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 25MG BASE/ML

Approval Date : 1982-03-31

Application Number : 11719

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 1GM BASE/VIAL

Approval Date : 1988-04-07

Application Number : 11719

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

METHOTREXATE SODIUM

Brand Name : METHOTREXATE SODIUM

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Approval Date : 2004-12-15

Application Number : 11719

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

METHOTREXATE SODIUM

Brand Name : METHOTREXATE PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)

Approval Date : 2005-04-13

Application Number : 11719

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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