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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040026
Company: CHARTWELL RX

Products on ANDA 040026

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040026

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40026ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2009	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/22/2007	SUPPL-6	Labeling		Label is not available on this site.
06/12/2006	SUPPL-5	Labeling		Label is not available on this site.
04/03/2006	SUPPL-4	Labeling		Label is not available on this site.
07/27/2005	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040026

PROMETHAZINE HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040026	CHARTWELL RX
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040891	NOSTRUM LABS INC
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	213890	QUAGEN
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040718	TARO
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	091675	TRIS PHARMA INC
PROMETHAZINE PLAIN	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	087953	WOCKHARDT BIO AG

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