Drugs@FDA: FDA Approved Drug Products

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

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

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