Application 216482

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYHIBBIN	MYCOPHENOLATE MOFETIL	SUSPENSION;ORAL	200MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N216482-001	MYHIBBIN	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL		RLD, RS	2024-05-01

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15
N216482-001	12097284	2039-08-16		Drug product	2024-09-27
N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27
N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16
N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216482-001	MYHIBBIN	200MG/ML	SUSPENSION / ORAL	RLD, RS	2024-05-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216482-001	12226526	2039-08-16	U-1752	Drug product	2025-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216482-001	12097284	2039-08-16		Drug product	2024-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216482-001	12097285	2039-08-16	U-1752	Drug product	2024-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216482-001	12194143	2039-08-16	U-1752	Drug product	2025-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216482-001	11931455	2039-08-16	U-1752	Drug product	2024-05-15	`03ed91905a0d…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Strides Pharma Science Limited	c1c4cb31-00a7-417e-9775-24e849d62791	2025-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	3ac54299-15cc-4c7a-8831-60c15a859b85	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	df3ba2e9-00bb-40af-8658-2c5fd2e398ef	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	American Health Packaging	8015f042-54fb-4a7a-a10b-6219e1a450c8	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Strides Pharma Science Limited	32dd890a-cfe3-4129-bce6-1d3dbe38e4f3	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Cardinal Health 107, LLC	f2eafcbb-77ab-461e-aa09-9cc4123eb3bd	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Wuxi Fortune Pharmaceutical Co.,Ltd.	ca633c6a-1e58-4faa-8e5d-71f89cefaa01	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	ONESOURCE SPECIALTY PHARMA LIMITED	461a252f-ff81-4e08-b256-a497b14835fa	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Amneal Pharmaceuticals NY LLC	5d7f7b88-79e3-4a56-a9f3-796c28049a60	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	afb59492-2bb1-4cf1-af4b-a5020b56c124	2025-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Advagen Pharma Limited	a15c26d8-5a27-48ba-a669-8546803d901f	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Camber Pharmaceuticals, Inc.	118e9bc8-c1a9-41d0-89e6-251f3be0b99c	2025-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CONCORD BIOTECH LIMITED	64ac00ee-298c-49cf-a91c-78019a0d014d	2025-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Sandoz Inc	99b2eb58-8d14-48fc-bbe1-aacb711a783e	2025-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Lannett Company, Inc.	24c0b94a-c141-44b6-a6f0-ade1669b254c	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Mylan Institutional LLC	da02b428-42a4-4007-b0b7-695f2db010f2	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Hikma Pharmaceuticals USA Inc.	e94895d9-f040-4a75-9f04-9814238b8f3c	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	AvKARE	339a10c4-e442-de9e-e063-6294a90a6208	2025-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	ARMAS PHARMACEUTICALS INC	ffcc237c-f31b-77b8-e053-6294a90a603e	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	American Health Packaging	75a76397-bb62-4014-8488-949a711b25f0	2025-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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