Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050594
Company: JOHNSON AND JOHNSON

Products on NDA 050594

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYCETTE	ERYTHROMYCIN	2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SWAB;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/1985	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
07/23/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/07/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/30/1997	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
12/15/1995	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
06/08/1995	SUPPL-19	Labeling		Label is not available on this site.
01/05/1995	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/18/1993	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
12/01/1992	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/15/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/08/1990	SUPPL-13	Labeling		Label is not available on this site.
12/14/1987	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/06/1987	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
10/09/1986	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/1986	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
01/13/1986	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/12/1985	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/28/1987	SUPPL-3	Labeling		Label is not available on this site.
09/19/1985	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/1985	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.