FDA.reportPublic FDA data

Application 216482

Type
NDA
Sponsor
AZURITY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYHIBBINMYCOPHENOLATE MOFETILSUSPENSION;ORAL200MG/MLYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216482-001MYHIBBINMYCOPHENOLATE MOFETIL200MG/MLSUSPENSION / ORALRLD, RS2024-05-01

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216482-001119314552039-08-16U-1752Drug product2024-05-15
N216482-001120972842039-08-16Drug product2024-09-27
N216482-001120972852039-08-16U-1752Drug product2024-09-27
N216482-001121941432039-08-16U-1752Drug product2025-01-16
N216482-001122265262039-08-16U-1752Drug product2025-02-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-011e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216482-001MYHIBBIN200MG/MLSUSPENSION / ORALRLD, RS2024-05-01a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216482-001119314552039-08-16U-1752Drug product2024-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216482-001120972842039-08-16Drug product2024-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216482-001120972852039-08-16U-1752Drug product2024-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216482-001121941432039-08-16U-1752Drug product2025-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216482-001122265262039-08-16U-1752Drug product2025-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216482-001119314552039-08-16U-1752Drug product2024-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216482-001120972842039-08-16Drug product2024-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216482-001120972852039-08-16U-1752Drug product2024-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216482-001121941432039-08-16U-1752Drug product2025-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216482-001122265262039-08-16U-1752Drug product2025-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N216482-001119314552039-08-16U-1752Drug product2024-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216482-001120972842039-08-16Drug product2024-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216482-001120972852039-08-16U-1752Drug product2024-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216482-001121941432039-08-16U-1752Drug product2025-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216482-001122265262039-08-16U-1752Drug product2025-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216482-001119314552039-08-16U-1752Drug product2024-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216482-001120972842039-08-16Drug product2024-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216482-001120972852039-08-16U-1752Drug product2024-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216482-001121941432039-08-16U-1752Drug product2025-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216482-001122265262039-08-16U-1752Drug product2025-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216482-001119314552039-08-16U-1752Drug product2024-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216482-001120972842039-08-16Drug product2024-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216482-001120972852039-08-16U-1752Drug product2024-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216482-001121941432039-08-16U-1752Drug product2025-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216482-001119314552039-08-16U-1752Drug product2024-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216482-001120972842039-08-16Drug product2024-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216482-001120972852039-08-16U-1752Drug product2024-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216482-001119314552039-08-16U-1752Drug product2024-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216482-001120972842039-08-16Drug product2024-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216482-001120972852039-08-16U-1752Drug product2024-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216482-001119314552039-08-16U-1752Drug product2024-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216482-001119314552039-08-16U-1752Drug product2024-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216482-001120972842039-08-16Drug product2024-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216482-001120972852039-08-16U-1752Drug product2024-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216482-001119314552039-08-16U-1752Drug product2024-05-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N216482-001120972842039-08-16Drug product2024-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N216482-001120972852039-08-16U-1752Drug product2024-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216482-001119314552039-08-16U-1752Drug product2024-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216482-001119314552039-08-16U-1752Drug product2024-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216482-001119314552039-08-16U-1752Drug product2024-05-151e350fbaab3a…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYHIBBINMYCOPHENOLATE MOFETILAzurity Pharmaceuticals, Inc.d9af72d6-7b3e-4c08-94b9-1d8b499cb7f92026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 216482
application number: NDA216482

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82713SUPPL 2025-06-30
82700SUPPL 2025-06-30
79793ORIG 2024-10-01
79432SUPPL 2024-08-19
78389ORIG 2024-05-03
78388ORIG 2024-05-03
78369ORIG 2024-05-02