Home Applications 050708 Application 050708
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROGRAF TACROLIMUS CAPSULE;ORAL EQ 1MG BASE Yes No 002 PROGRAF TACROLIMUS CAPSULE;ORAL EQ 5MG BASE Yes Yes 003 PROGRAF TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N050708-001 PROGRAF TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 N050708-002 PROGRAF TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 N050708-003 PROGRAF TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N050708-001 ODE-360 2028-07-16 N050708-002 ODE-360 2028-07-16 N050708-003 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 2 of 4 · 132 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050708-003 PROGRAF EQ 0.5MG BASE CAPSULE / ORAL AB RLD 1998-08-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050708-001 PROGRAF EQ 1MG BASE CAPSULE / ORAL AB RLD 1994-04-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050708-002 PROGRAF EQ 5MG BASE CAPSULE / ORAL AB RLD, RS 1994-04-08 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 213 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0607 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0617 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-0657 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 21695-170 Prograf Tacrolimus Rebel Distributors Corp NDA Current 43353-178 Prograf Tacrolimus Aphena Pharma Solutions - Tennessee, LLC NDA Current