Home Applications 050689 Application 050689
Type NDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYCOBUTIN RIFABUTIN CAPSULE;ORAL 150MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050689-001 MYCOBUTIN RIFABUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050689-001 AB
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 · 41 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 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0013-5301 Mycobutin rifabutin Pharmacia and Upjohn Company LLC NDA Current 0013-5301 Mycobutin rifabutin Pfizer Laboratories Div Pfizer Inc NDA Current 0013-5301 Mycobutin rifabutin Pfizer Laboratories Div Pfizer Inc NDA Current 0013-5301 Mycobutin rifabutin Pharmacia and Upjohn Company LLC NDA Current 0013-5301 Mycobutin rifabutin Pfizer Laboratories Div Pfizer Inc NDA Current 0013-5301 Mycobutin rifabutin Pharmacia and Upjohn Company LLC NDA Current 55695-010 Mycobutin rifabutin Department of State Health Services, Pharmacy Branch NDA Current 59762-1350 Rifabutin rifabutin Greenstone LLC NDA Current 59762-1350 Rifabutin rifabutin Greenstone LLC NDA Current 59762-1350 Rifabutin rifabutin Greenstone LLC NDA Current