Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040151
Company: HIKMA

Products on ANDA 040151

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/1997	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-26	Labeling-Package Insert		Label is not available on this site.
06/28/2018	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/19/2018	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-18	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/13/2017	SUPPL-15	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.
04/26/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/09/2009	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/19/2008	SUPPL-7	Labeling		Label is not available on this site.
02/25/2008	SUPPL-6	Labeling		Label is not available on this site.
02/04/2008	SUPPL-3	Labeling		Label is not available on this site.
02/17/2006	SUPPL-2	Labeling		Label is not available on this site.