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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200963
Company: AMNEAL PHARMS

Products on ANDA 200963

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2015	ORIG-1	Approval	Not Applicable			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-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/28/2018	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/08/2018	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
01/13/2017	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200963

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040660	PHARM ASSOC
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	200963	AMNEAL PHARMS

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