Application 213955

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	FOR SUSPENSION;ORAL	200MG/ML	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
A213955-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB		2023-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213955-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213955-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2023-09-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213955-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213955-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213955-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213955-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213955-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213955-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213955-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213955-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213955-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213955-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213955-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213955-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213955-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213955-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213955-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213955-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213955-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213955-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213955-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213955-001	AB	1	`a50c72e98297…`

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 · 47 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	32dd890a-cfe3-4129-bce6-1d3dbe38e4f3	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil 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 brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
CellCept	MYCOPHENOLATE MOFETIL	Genentech, Inc.	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	2025-11-25	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 brand name: Mycophenolate Mofetil 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 brand name: mycophenolate mofetil 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 brand name: Mycophenolate Mofetil 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 brand name: Mycophenolate mofetil 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 brand name: MYCOPHENOLATE MOFETIL 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 brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Teva Pharmaceuticals USA, Inc.	b414303f-e6f3-4e22-a537-96be352b59a4	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil 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 brand name: MYCOPHENOLATE MOFETIL 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 brand name: Mycophenolate Mofetil 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 brand name: Mycophenolate Mofetil 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 brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Aurobindo Pharma Limited	3eb584dc-f72d-4545-96fa-ab3d47be41ce	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Aurobindo Pharma Limited	20fa7709-a203-481f-aaf4-e98fab1acd0d	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLATE MOFETIL generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Aurobindo Pharma Limited	8faf357b-99a1-440b-8eac-8545cb19a69c	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Amneal Pharmaceuticals NY LLC	27fd9381-8d82-4187-897f-98f41f94e90f	2025-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil 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 brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	84c6f6bb-8924-4da5-9629-126197195f83	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76509	ORIG	2023-11-07