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 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
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 · 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	A065457-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL		2009-05-04	`84e616aacf4f…`
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…`

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 3 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	ARMAS PHARMACEUTICALS INC	ffcc237c-f31b-77b8-e053-6294a90a603e	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolate mofetil 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 brand name: mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	NuCare Pharmaceuticals, Inc.	2b9ae8ff-f2bc-ccef-e063-6294a90a76da	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL	Aphena Pharma Solutions - Tennessee, LLC	721564bc-7c0b-4418-ab49-0af362e74eb7	2024-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolate Mofetil generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Proficient Rx LP	ce06afcb-4e6c-4b78-8bad-9909c8fffa52	2023-10-01	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 · 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