FDA.reportPublic FDA data

Application 078183

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN EXTENDED RELEASECIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL212.6MG;EQ 287.5MG BASENoNo
002CIPROFLOXACIN EXTENDED RELEASECIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL425.2MG;EQ 574.9MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078183-001CIPROFLOXACIN EXTENDED RELEASECIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE212.6MG;EQ 287.5MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22
A078183-002CIPROFLOXACIN EXTENDED RELEASECIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE425.2MG;EQ 574.9MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A078183-001CIPROFLOXACIN EXTENDED RELEASE212.6MG;EQ 287.5MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078183-002CIPROFLOXACIN EXTENDED RELEASE425.2MG;EQ 574.9MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078183-001CIPROFLOXACIN EXTENDED RELEASE212.6MG;EQ 287.5MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22e64feba35796…
2022-09-29 23:25 UTC2022-09A078183-002CIPROFLOXACIN EXTENDED RELEASE425.2MG;EQ 574.9MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078183-001CIPROFLOXACIN EXTENDED RELEASE212.6MG;EQ 287.5MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078183-002CIPROFLOXACIN EXTENDED RELEASE425.2MG;EQ 574.9MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078183-001CIPROFLOXACIN EXTENDED RELEASE212.6MG;EQ 287.5MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078183-002CIPROFLOXACIN EXTENDED RELEASE425.2MG;EQ 574.9MG BASETABLET, EXTENDED RELEASE / ORAL2007-03-22a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1743CiprofloxacinciprofloxacinMylan Pharmaceuticals Inc.ANDACurrent
0378-1743CiprofloxacinciprofloxacinMylan Pharmaceuticals Inc.ANDACurrent
0378-1745CiprofloxacinciprofloxacinMylan Pharmaceuticals Inc.ANDACurrent
0378-1745CiprofloxacinciprofloxacinMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31342ORIG2007-03-31