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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219470
Company: ANNORA PHARMA

Products on ANDA 219470

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219470

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219470

DIPHENHYDRAMINE HYDROCHLORIDE

ELIXIR;ORAL; 12.5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	219470	ANNORA PHARMA
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Prescription	Yes	AA	087513	PHARM ASSOC

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