Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201094
Company: SAGENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYDO LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL Prescription AT No 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
04/28/2014 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201094Orig1s000ltr.pdf

GLYDO

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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