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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021598
Company: HARROW EYE

Products on NDA 021598

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT1	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021598

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-598_Vigamox.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2020	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21598s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021598Orig1s024ltr.pdf
05/11/2020	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021598s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021598Orig1s023ltr.pdf
03/14/2017	SUPPL-22	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021598Orig1s022ltr.pdf
10/07/2011	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021598s017ltr.pdf
06/25/2004	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf
10/03/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf
04/12/2004	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf
10/03/2003	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf

Labels for NDA 021598

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21598s024lbl.pdf
05/11/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021598s023lbl.pdf
03/14/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf
03/14/2017	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf
10/07/2011	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf
06/25/2004	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf
04/12/2004	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf
10/03/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf
10/03/2003	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf
04/15/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf

Therapeutic Equivalents for NDA 021598

VIGAMOX

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	209469	ALEMBIC
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	090080	APOTEX
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	206242	EUGIA PHARMA
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	208778	GLAND
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	202867	LUPIN
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	217988	MANKIND PHARMA
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	202525	REGCON HOLDINGS
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	209698	SOMERSET THERAPS LLC
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	212616	UPSHER SMITH LABS
VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	021598	HARROW EYE

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