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Approved Drug Products containing Promethazine HCl 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

PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date : 2017-06-30

Application Number : 209177

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

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PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : SUPPOSITORY;RECTAL

Dosage Strength : 12.5MG

Approval Date : 2006-10-26

Application Number : 40603

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : SUPPOSITORY;RECTAL

Dosage Strength : 25MG

Approval Date : 2006-10-26

Application Number : 40603

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

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PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : SYRUP;ORAL

Dosage Strength : 6.25MG/5ML

Approval Date : 2007-04-04

Application Number : 40718

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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05

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2017-06-30

Application Number : 209177

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

06

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AB

PROMETHAZINE HYDROCHLORIDE

Brand Name : PROMETHAZINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2017-06-30

Application Number : 209177

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

07

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CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Brand Name : PHENERGAN W/ CODEINE

Dosage Form : SYRUP;ORAL

Dosage Strength : 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-04-02

Application Number : 8306

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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Not Confirmed
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PROMETHAZINE HYDROCHLORIDE

Brand Name : PHENERGAN

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 7935

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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Not Confirmed
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Not Confirmed

PROMETHAZINE HYDROCHLORIDE

Brand Name : PHENERGAN

Dosage Form : TABLET;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 : 7935

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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Not Confirmed
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Not Confirmed

PROMETHAZINE HYDROCHLORIDE

Brand Name : PHENERGAN

Dosage Form : TABLET;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 : 7935

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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