Application 065457

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065457-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL			2009-05-04

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 · 42 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
2026-08-18 06:07:40	2026-07	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2009-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A065457-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065457-001	AB	1	`ea99ee380514…`

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 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	A-S Medication Solutions	b4170ad9-67f0-42ea-b694-6b80824a607a	2026-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	QUAGEN PHARMACEUTICALS LLC	838449b3-4397-4e35-b9b9-683f5a48bff2	2026-08-06	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	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Meitheal Pharmaceuticals Inc.	b41cca9f-0922-4171-8d1b-8e0d32ae1cc1	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Major Pharmaceuticals	6abc5727-ee8e-43ad-ab39-0eef2feb257a	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	d203775c-bf36-460c-bacf-3ab2348a514f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLATE MOFETIL generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	77a75d5b-a90d-4ee5-aa8a-6da97d130357	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Ascend Laboratories, LLC	21ff53b0-b4ba-4473-91e4-76ef41681064	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Bryant Ranch Prepack	0f1704e2-a66a-4be5-8127-ebb5947c7b64	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Par Health USA, LLC	35ba0428-e267-49a5-99a9-c58853f7989d	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Accord Healthcare Inc.	741e079a-646b-47ec-84ac-8e12574c2aaf	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Meitheal Pharmaceuticals Inc.	9650af9b-d36f-4a2f-9647-d0f798933402	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
MYHIBBIN	MYCOPHENOLATE MOFETIL	Azurity Pharmaceuticals, Inc.	d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Ascend Laboratories, LLC	9f84ea84-2d8b-4d91-a33f-7dfb5df937dc	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Major Pharmaceuticals	d176199c-dc3f-48c8-b7d2-c5d0a6a242fe	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	VistaPharm, LLC	175d8b87-e06a-4c9e-b3de-378114b52274	2026-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Camber Pharmaceuticals, Inc.	c3ded171-89da-4644-9ee8-dbcf6258036f	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
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	AvPAK	fbbe6521-0e21-5372-e053-6394a90ae5e4	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	BPI Labs LLC	32001417-130d-4c08-8e63-94ba3627ce5f	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7477	mycophenolate mofetil	mycophenolate mofetil	Teva Pharmaceuticals USA,	ANDA	Current
0093-7477	mycophenolate mofetil	mycophenolate mofetil	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24044	ORIG	2015-07-06
23749	ORIG	2009-07-15