Home Applications 065390 Application 065390
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RIFAMPIN RIFAMPIN CAPSULE;ORAL 150MG No No 002 RIFAMPIN RIFAMPIN CAPSULE;ORAL 300MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065390-001 RIFAMPIN RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 A065390-002 RIFAMPIN RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1315 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 0527-1393 Rifampin Rifampin Lannett Company, Inc. ANDA Current 42254-039 Rifampin Rifampin Rebel Distributors Corp ANDA Current 50090-0963 Rifampin Rifampin A-S Medication Solutions ANDA Current 50090-2633 Rifampin Rifampin A-S Medication Solutions ANDA Current 68084-357 Rifampin Rifampin American Health Packaging ANDA Current 68084-357 Rifampin Rifampin American Health Packaging ANDA Current 68084-357 Rifampin Rifampin American Health Packaging ANDA Current 68084-357 Rifampin Rifampin American Health Packaging ANDA Current 68084-358 Rifampin Rifampin American Health Packaging ANDA Current 68084-358 Rifampin Rifampin American Health Packaging ANDA Current 68084-358 Rifampin Rifampin American Health Packaging ANDA Current 68084-358 Rifampin Rifampin American Health Packaging ANDA Current