Home Applications 050709 Application 050709
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROGRAF TACROLIMUS INJECTABLE;INJECTION EQ 5MG BASE/ML 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 N050709-001 PROGRAF TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050709-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N050709-001 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 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 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prograf TACROLIMUS Astellas Pharma US, Inc. 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b 2023-08-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050709 application number: NDA050709 ndc (product): 0469-3016
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current 0469-3016 Prograf Tacrolimus Astellas Pharma US, Inc. NDA Current