Home Applications 210115 Application 210115
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROGRAF TACROLIMUS FOR SUSPENSION;ORAL EQ 0.2MG BASE/PACKET Yes No 002 PROGRAF TACROLIMUS FOR SUSPENSION;ORAL EQ 1MG BASE/PACKET 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 N210115-001 PROGRAF TACROLIMUS EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 N210115-002 PROGRAF TACROLIMUS EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210115-001 ODE-360 2028-07-16 N210115-002 ODE-360 2028-07-16
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 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 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210115-001 PROGRAF EQ 0.2MG BASE/PACKET FOR SUSPENSION / ORAL RLD 2018-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210115-002 PROGRAF EQ 1MG BASE/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-05-24 bb7c543d1eb4…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1230 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-1330 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current