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

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

AMANTADINE HYDROCHLORIDE

Brand Name : AMANTADINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2017-06-09

Application Number : 209035

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

AMANTADINE HYDROCHLORIDE

Brand Name : AMANTADINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2017-06-07

Application Number : 209047

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

AMANTADINE HYDROCHLORIDE

Brand Name : AMANTADINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2022-02-18

Application Number : 211354

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

04

BioProcess International
Not Confirmed
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BioProcess International
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AMANTADINE HYDROCHLORIDE

Brand Name : SYMMETREL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 16020

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

AMANTADINE HYDROCHLORIDE

Brand Name : SYMMETREL

Dosage Form : SYRUP;ORAL

Dosage Strength : 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 16023

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

AMANTADINE HYDROCHLORIDE

Brand Name : SYMMETREL

Dosage Form : SYRUP; ORAL

Dosage Strength : 50MG/5ML

Approval Date :

Application Number : 17118

RX/OTC/DISCN :

RLD :

TE Code :

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07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

AMANTADINE HYDROCHLORIDE

Brand Name : SYMMETREL

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18101

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

AMANTADINE HYDROCHLORIDE

Brand Name : AMANTADINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1987-02-18

Application Number : 71293

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

AMANTADINE HYDROCHLORIDE

Brand Name : SYMADINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1986-09-04

Application Number : 71000

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

AMANTADINE HYDROCHLORIDE

Brand Name : AMANTADINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1986-08-05

Application Number : 70589

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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