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Generated: June 27, 2017

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Details for New Drug Application (NDA): 200963

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NDA 200963 describes PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, which is a drug marketed by Amneal Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for NDA: 200963

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 200963

Suppliers and Packaging for NDA: 200963

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL 200963 ANDA Amneal Pharmaceuticals LLC 65162-694 65162-694-86 118 mL in 1 BOTTLE (65162-694-86)
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
SYRUP;ORAL 200963 ANDA Amneal Pharmaceuticals LLC 65162-694 65162-694-90 473 mL in 1 BOTTLE (65162-694-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;5MG/5ML;6.25MG/5ML
Approval Date:Aug 26, 2015TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Merck
Dow
Healthtrust
Covington
Cerilliant
Queensland Health
Teva
Express Scripts
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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