Home Applications 020392 Application 020392
Type NDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CYSTAGON CYSTEAMINE BITARTRATE CAPSULE;ORAL EQ 50MG BASE Yes No 002 CYSTAGON CYSTEAMINE BITARTRATE CAPSULE;ORAL EQ 150MG BASE Yes Yes
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 N020392-001 CYSTAGON CYSTEAMINE BITARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 N020392-002 CYSTAGON CYSTEAMINE BITARTRATE EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15
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 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020392-001 CYSTAGON EQ 50MG BASE CAPSULE / ORAL RLD 1994-08-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020392-002 CYSTAGON EQ 150MG BASE CAPSULE / ORAL RLD, RS 1994-08-15 bb7c543d1eb4…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-9040 Cystagon cysteamine bitartrate Mylan Pharmaceuticals Inc. NDA Current 0378-9040 Cystagon cysteamine bitartrate Mylan Pharmaceuticals Inc. NDA Current 0378-9040 Cystagon cysteamine bitartrate Mylan Pharmaceuticals Inc. NDA Current 0378-9045 Cystagon cysteamine bitartrate Mylan Pharmaceuticals Inc. NDA Current 0378-9045 Cystagon cysteamine bitartrate Mylan Pharmaceuticals Inc. NDA Current 0378-9045 Cystagon cysteamine bitartrate Mylan Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 24899 SUPPL 2007-06-14 12531 SUPPL 2007-06-07 2467 SUPPL 2004-02-03 24898 SUPPL 2001-04-11