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

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PharmaCompass

01

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INDOMETHACIN

Brand Name : INDOMETHACIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 1984-07-31

Application Number : 18690

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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INDOMETHACIN

Brand Name : INDOMETHACIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Approval Date : 1984-07-31

Application Number : 18690

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

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INDOMETHACIN

Brand Name : INDOCIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 16059

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

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INDOMETHACIN

Brand Name : INDOCIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 16059

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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INDOMETHACIN

Brand Name : INDOCIN

Dosage Form : SUPPOSITORY;RECTAL

Dosage Strength : 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-08-13

Application Number : 17814

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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INDOMETHACIN

Brand Name : INDOCIN SR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-02-23

Application Number : 18185

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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INDOMETHACIN

Brand Name : INDOCIN

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 25MG/5ML

Approval Date : 1985-10-10

Application Number : 18332

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

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INDOMETHACIN

Brand Name : INDOMETHACIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 1984-05-04

Application Number : 18730

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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INDOMETHACIN

Brand Name : INDOMETHACIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Approval Date : 1984-05-04

Application Number : 18730

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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INDOMETHACIN

Brand Name : INDOMETHACIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 1984-11-23

Application Number : 18806

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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