Home Applications 050614 Application 050614
Type NDA
Sponsor LILLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KEFTAB CEPHALEXIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE No No 002 KEFTAB CEPHALEXIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE No No 003 KEFTAB CEPHALEXIN HYDROCHLORIDE TABLET;ORAL EQ 333MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050614-001 KEFTAB CEPHALEXIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 1987-10-29 N050614-002 KEFTAB CEPHALEXIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 1987-10-29 N050614-003 KEFTAB CEPHALEXIN HYDROCHLORIDE EQ 333MG BASE TABLET / ORAL 1988-05-16
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 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050614-002 KEFTAB EQ 500MG BASE TABLET / ORAL 1987-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050614-003 KEFTAB EQ 333MG BASE TABLET / ORAL 1988-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050614-001 KEFTAB EQ 250MG BASE TABLET / ORAL 1987-10-29 8072bd15b7f6…