Home Applications 214283 Application 214283
Type ANDA
Sponsor BPI LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE INJECTABLE;INJECTION 500MG/VIAL No No
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 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214283-001 AP
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.
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 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214283-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2023-06-01 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Documents# Document, Submission type, Date table Document Submission type Date 76284 ORIG 2023-11-03 74428 ORIG 2023-06-05