Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005845
Company: MCNEIL CONS

Products on NDA 005845

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	50MG	CAPSULE;ORAL	Discontinued	None	No	No
BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	12.5MG/5ML	ELIXIR;ORAL	Discontinued	None	No	No
BENADRYL	DIPHENHYDRAMINE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005845

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/1946	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/1987	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
05/19/1986	SUPPL-43	Labeling		Label is not available on this site.
05/19/1986	SUPPL-42	Labeling		Label is not available on this site.
08/02/1985	SUPPL-41	Labeling		Label is not available on this site.
08/02/1985	SUPPL-40	Labeling		Label is not available on this site.
08/07/1985	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
05/19/1986	SUPPL-38	Labeling		Label is not available on this site.
05/19/1986	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
08/30/1984	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/1984	SUPPL-31	Efficacy		Label is not available on this site.