Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017433
Company: DAVIS AND GECK

Products on NDA 017433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRE-OP	HEXACHLOROPHENE	480MG	SPONGE;TOPICAL	Prescription	AT	Yes	Yes
PRE-OP II	HEXACHLOROPHENE	480MG	SPONGE;TOPICAL	Prescription	AT	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/1978	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
05/07/1992	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/01/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/28/1989	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/30/1985	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/23/1985	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/25/1985	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/05/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/28/1983	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/28/1983	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1982	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/30/1982	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/01/1980	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/26/1980	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/11/1980	SUPPL-2	Labeling		Label is not available on this site.
12/01/1980	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for NDA 017433

PRE-OP

SPONGE;TOPICAL; 480MG
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PRE-OP	HEXACHLOROPHENE	480MG	SPONGE;TOPICAL	Prescription	Yes	AT	017433	DAVIS AND GECK
PRE-OP II	HEXACHLOROPHENE	480MG	SPONGE;TOPICAL	Prescription	Yes	AT	017433	DAVIS AND GECK

PRE-OP II

SPONGE;TOPICAL; 480MG
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PRE-OP	HEXACHLOROPHENE	480MG	SPONGE;TOPICAL	Prescription	Yes	AT	017433	DAVIS AND GECK
PRE-OP II	HEXACHLOROPHENE	480MG	SPONGE;TOPICAL	Prescription	Yes	AT	017433	DAVIS AND GECK