Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214238
Company: QUAGEN

Products on ANDA 214238

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214238

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 214238

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

SYRUP;ORAL; 10MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	200894	AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	090180	NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	214238	QUAGEN
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	200386	TRIS PHARMA INC
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	088875	WOCKHARDT BIO AG