Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201094
Company: SAGENT PHARMS INC

Products on ANDA 201094

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYDO	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201094

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201094

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 INC
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Prescription	No	AT	086283	INTL MEDICATION
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY;TOPICAL	Prescription	No	AT	040433	SENTISS