FDA.reportPublic FDA data

Application 021493

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYMARGATIFLOXACINSOLUTION/DROPS;OPHTHALMIC0.3%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021493-001ZYMARGATIFLOXACIN0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2003-03-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021493-001ZYMAR0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2003-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021493-001ZYMAR0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2003-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021493-001ZYMAR0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS2003-03-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021493-001ZYMAR0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2003-03-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021493-00163330452019-08-20Drug product, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021493-0016333045*PED2020-02-20Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021493-0016333045*PED2020-02-20Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021493-0016333045*PED2020-02-20Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021493-00163330452019-08-20Drug product, Delist requested3f01610625f2…
2019-12-14 00:12 UTC2019-12N021493-0016333045*PED2020-02-20Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021493-00163330452019-08-20Drug product, Delist requestedb00525d2431f…
2019-09-15 20:21 UTC2019-09N021493-0016333045*PED2020-02-20Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021493-00163330452019-08-20Drug product, Delist requestedea99ee380514…
2019-07-19 19:46 UTC2019-07N021493-0016333045*PED2020-02-20Pediatric extensionea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GATIFLOXACINGATIFLOXACINLeading Pharma, LLC826cf8c4-4be5-4614-bd42-47c1d0c9df582025-10-28Warnings, Adverse reactionsName fallback
generic name: GATIFLOXACIN
GatifloxacinGATIFLOXACINSandoz Inc9e6fcd14-1fee-493f-811c-e18cbfbee65b2025-02-15Warnings, Adverse reactionsName fallback
generic name: GATIFLOXACIN
ZYMAXIDGATIFLOXACINAllergan, Inc.1160b16c-929a-4e85-9c0b-1d8c96a7678b2016-09-08Warnings, Adverse reactionsName fallback
generic name: GATIFLOXACIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47683SUPPL2017-03-24
47632SUPPL2017-03-22
54221SUPPL2017-03-21
37070SUPPL2015-05-27
5542SUPPL2015-05-22
51933SUPPL2009-05-19
51932SUPPL2009-05-19
51931SUPPL2009-05-19
51930SUPPL2009-05-19
51929SUPPL2009-05-19
37069SUPPL2005-06-21
27929SUPPL2005-06-21
15599SUPPL2005-06-21
5541SUPPL2005-06-21
42192ORIG2005-05-02
37068ORIG2003-04-01
27928ORIG2003-04-01