Application 065058

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFACLORCEFACLORTABLET, EXTENDED RELEASE;ORALEQ 375MG BASENoNo
002CEFACLORCEFACLORTABLET, EXTENDED RELEASE;ORALEQ 500MG BASENoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065058-001CEFACLORCEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-04
A065058-002CEFACLORCEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-04

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-01-26 05:58 UTC2023-01A065058-001CEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-043bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065058-002CEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065058-001CEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-043a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065058-002CEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065058-001CEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-04f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065058-002CEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065058-001CEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-04e64feba35796…
2022-09-29 23:25 UTC2022-09A065058-002CEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065058-001CEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-04cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065058-002CEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-04cb3db0bc1861…
2026-08-01 22:54:322026-06A065058-001CEFACLOREQ 375MG BASETABLET, EXTENDED RELEASE / ORAL2002-09-04a50c72e98297…
2026-08-01 22:54:322026-06A065058-002CEFACLOREQ 500MG BASETABLET, EXTENDED RELEASE / ORALRS2002-09-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefaclorCEFACLORTeva Pharmaceuticals USA, Inc.0878bdc2-0410-4938-9890-96523aa81c2f2019-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065058
application number: ANDA065058
ndc (product): 0093-1087

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1087CefaclorCefaclorTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1087CefaclorCefaclorTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1087CefaclorCefaclorTeva Pharmaceuticals USA, Inc.ANDACurrent