Application 063024

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEPHALEXINCEPHALEXINTABLET;ORALEQ 500MG BASENoYes
002CEPHALEXINCEPHALEXINTABLET;ORALEQ 250MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A063024-001CEPHALEXINCEPHALEXINEQ 500MG BASETABLET / ORALABRS1989-01-12
A063024-002CEPHALEXINCEPHALEXINEQ 250MG BASETABLET / ORALAB1989-01-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A063024-001AB
A063024-002AB

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 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALABRS1989-01-12caaa826d4ba7…
2026-08-18 06:07:402026-07A063024-002CEPHALEXINEQ 250MG BASETABLET / ORALAB1989-01-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063024-002CEPHALEXINEQ 250MG BASETABLET / ORAL1989-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063024-002CEPHALEXINEQ 250MG BASETABLET / ORAL1989-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-123f01610625f2…
2019-09-15 20:21 UTC2019-09A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-123bdfa0b2c4d7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A063024-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A063024-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063024-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063024-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINTeva Pharmaceuticals USA, Inc.445b2a87-2e4f-483a-abe8-26fefd67514a2023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063024
application number: ANDA063024
ndc (product): 0093-2240

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2240CephalexinCephalexinTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39403SUPPL2012-07-30