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

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01 3SANOFI AVENTIS US

02 2ACTAVIS LABS FL INC

03 1BIONPHARMA

04 1CHATTEM

05 1COPLEY PHARM

06 2DUCHESNAY

07 1ENDO OPERATIONS

08 1LNK

09 1MYLAN PHARMS INC

10 1PAR PHARM

11 1PERRIGO

12 1PFIZER

13 1QUANTUM PHARMICS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

DOXYLAMINE SUCCINATE

Brand Name : DECAPRYN

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1982-01-01

Application Number : 6412

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

DOXYLAMINE SUCCINATE

Brand Name : DECAPRYN

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date : 1982-01-01

Application Number : 6412

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Brand Name : BENDECTIN

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 10598

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

04

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DOXYLAMINE SUCCINATE

Brand Name : UNISOM

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1982-01-01

Application Number : 18066

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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05

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DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Brand Name : DICLEGIS

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 10MG;10MG

Approval Date : 2013-04-08

Application Number : 21876

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

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DOXYLAMINE SUCCINATE

Brand Name : DOXYLAMINE SUCCINATE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2004-08-27

Application Number : 40564

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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07

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DOXYLAMINE SUCCINATE

Brand Name : DOXY-SLEEP-AID

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1987-07-02

Application Number : 70156

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

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DOXYLAMINE SUCCINATE

Brand Name : DOXYLAMINE SUCCINATE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1996-09-18

Application Number : 40167

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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09

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DOXYLAMINE SUCCINATE

Brand Name : UNISOM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 25MG

Approval Date : 1986-02-05

Application Number : 19440

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

QUANTUM PHARMICS

Country
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QUANTUM PHARMICS

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DOXYLAMINE SUCCINATE

Brand Name : DOXYLAMINE SUCCINATE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 1984-08-07

Application Number : 88603

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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