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

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01

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DICYCLOMINE HYDROCHLORIDE

Brand Name : BENTYL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1984-10-15

Application Number : 8370

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

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DICYCLOMINE HYDROCHLORIDE

Brand Name : BENTYL

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-10-15

Application Number : 7409

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie CB

03

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RLD : No

TE Code :

DICYCLOMINE HYDROCHLORIDE

Brand Name : DICYCLOMINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1986-02-11

Application Number : 80614

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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DICYCLOMINE HYDROCHLORIDE

Brand Name : BENTYL PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1984-10-15

Application Number : 8370

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

05

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DICYCLOMINE HYDROCHLORIDE

Brand Name : BENTYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-10-15

Application Number : 7409

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie CB

06

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DICYCLOMINE HYDROCHLORIDE

Brand Name : BENTYL

Dosage Form : SYRUP;ORAL

Dosage Strength : 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-10-15

Application Number : 7961

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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DICYCLOMINE HYDROCHLORIDE

Brand Name : DICYCLOMINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 1996-10-01

Application Number : 40161

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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DICYCLOMINE HYDROCHLORIDE

Brand Name : DICYCLOMINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 1999-02-26

Application Number : 40230

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

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DICYCLOMINE HYDROCHLORIDE

Brand Name : DICYCLOMINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Approval Date : 1997-02-28

Application Number : 40204

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

ENDO OPERATIONS

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ENDO OPERATIONS

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DICYCLOMINE HYDROCHLORIDE

Brand Name : DICYCLOMINE HYDROCHLORIDE

Dosage Form : SYRUP;ORAL

Dosage Strength : 10MG/5ML

Approval Date : 2005-03-24

Application Number : 40169

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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