Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008816
Company: OAK PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/12/1953 ORIG-1 Approval Type 3 - New Dosage Form 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
11/02/2018 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008816s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008816Orig1s039Ltr.pdf
10/24/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/24/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/28/2012 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/23/2004 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08816s032ltr.pdf
06/02/2000 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1999 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/07/1998 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/07/1990 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1987 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1987 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/20/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/11/1984 SUPPL-13 Labeling

Label is not available on this site.

07/11/1984 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/25/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1984 SUPPL-8 Labeling

Label is not available on this site.

02/23/1981 SUPPL-7 Labeling

Label is not available on this site.

02/23/1981 SUPPL-6 Efficacy

Label is not available on this site.

02/16/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/02/1977 SUPPL-4 Labeling

Label is not available on this site.

01/12/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1977 SUPPL-2 Labeling

Label is not available on this site.

03/06/1973 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/02/2018 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008816s039lbl.pdf
07/23/2004 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf

XYLOCAINE

JELLY;TOPICAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYDO LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 201094 SAGENT PHARMS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 040433 AKORN
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription No AT 086283 INTL MEDICATION
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription Yes AT 008816 OAK PHARMS

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