Home Applications 050698 Application 050698
Type NDA
Sponsor ABBVIE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BIAXIN CLARITHROMYCIN FOR SUSPENSION;ORAL 125MG/5ML Yes No 002 BIAXIN CLARITHROMYCIN FOR SUSPENSION;ORAL 250MG/5ML Yes No 003 BIAXIN CLARITHROMYCIN FOR SUSPENSION;ORAL 187MG/5ML 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 N050698-001 BIAXIN CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 N050698-002 BIAXIN CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 N050698-003 BIAXIN CLARITHROMYCIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30
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 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050698-002 BIAXIN 250MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050698-003 BIAXIN 187MG/5ML FOR SUSPENSION / ORAL 1998-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050698-001 BIAXIN 125MG/5ML FOR SUSPENSION / ORAL RLD 1993-12-23 8072bd15b7f6…
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 3 of 3 · 42 matching rows.