An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040650
Company: PHARM ASSOC

Products on ANDA 040650

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE WITH CODEINE	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 040650

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2006	ORIG-1	Approval				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-29	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/28/2018	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
06/19/2018	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2017	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2017	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/13/2017	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/10/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/08/2009	SUPPL-6	Labeling		Label is not available on this site.
12/19/2008	SUPPL-3	Labeling		Label is not available on this site.
02/25/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040650

PROMETHAZINE WITH CODEINE

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
PROMETHAZINE WITH CODEINE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040650	PHARM ASSOC

Top