Application 210370

Type: ANDA
Sponsor: VISTAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	SUSPENSION;ORAL	200MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210370-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB		2019-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210370-001	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.

Product history page 1 of 2 · 43 observed 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
2026-09-14 22:38:34	2026-08	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	SUSPENSION / ORAL	AB	2019-02-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210370-001	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION / ORAL	AB	2019-02-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210370-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210370-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210370-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210370-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210370-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210370-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210370-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210370-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210370-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210370-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210370-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210370-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210370-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210370-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210370-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210370-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210370-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210370-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210370-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210370-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210370-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210370-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210370-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210370-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210370-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210370-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210370-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210370-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210370-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210370-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210370-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210370-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210370-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210370-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210370-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210370-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210370-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210370-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210370-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210370-001	AB	1	`f41ea6bd6efb…`

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 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	NorthStar Rx LLC	127eabe2-8386-452a-ad6b-d879e1f2c099	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLATE MOFETIL generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Strides Pharma Science Limited	c1c4cb31-00a7-417e-9775-24e849d62791	2025-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLATE MOFETIL 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 brand name: Mycophenolate mofetil 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 brand name: MYCOPHENOLATE MOFETIL 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 brand name: Mycophenolate mofetil 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 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
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	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	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	AvKARE	339a10c4-e442-de9e-e063-6294a90a6208	2025-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL

Reported adverse events (FAERS/openFDA)#

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

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
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, LLC	ANDA	Current
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, LLC	ANDA	Current
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, Inc.	ANDA	Current
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, Inc.	ANDA	Current
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, Inc.	ANDA	Current
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, Inc.	ANDA	Current
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil	VistaPharm, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76494	ORIG	2023-11-07