Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050237
Company: BAYER PHARMS

Products on NDA 050237

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEO-CORT-DOME	HYDROCORTISONE; NEOMYCIN SULFATE	1%;EQ 3.5MG BASE/GM	CREAM;TOPICAL	Discontinued	None	No	No
NEO-CORT-DOME	HYDROCORTISONE; NEOMYCIN SULFATE	0.5%;EQ 3.5MG BASE/GM	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050237

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/1964	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
03/21/1980	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/1985	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/05/1984	SUPPL-2	Labeling		Label is not available on this site.
07/05/1983	SUPPL-1	Labeling		Label is not available on this site.