Application 090456

Type: ANDA
Sponsor: STRIDES PHARMA

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 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
A090456-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB		2010-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090456-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090456-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2010-06-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090456-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090456-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090456-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090456-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090456-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090456-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090456-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090456-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090456-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090456-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090456-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090456-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090456-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090456-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090456-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090456-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090456-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090456-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090456-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090456-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090456-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090456-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090456-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090456-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090456-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090456-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090456-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090456-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090456-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090456-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090456-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090456-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090456-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090456-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090456-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090456-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090456-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090456-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090456-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090456-001	AB	1	`cb3db0bc1861…`

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Major Pharmaceuticals	d176199c-dc3f-48c8-b7d2-c5d0a6a242fe	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456 ndc (product): 0904-7078
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	Exact identifier application applno (ANDA): 090456 application number: ANDA090456 ndc (product): 23155-836
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	American Health Packaging	8015f042-54fb-4a7a-a10b-6219e1a450c8	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456 ndc (product): 60687-438
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Strides Pharma Science Limited	32dd890a-cfe3-4129-bce6-1d3dbe38e4f3	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456 ndc (product): 64380-725
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Cardinal Health 107, LLC	f2eafcbb-77ab-461e-aa09-9cc4123eb3bd	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456 ndc (product): 55154-3571
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	afb59492-2bb1-4cf1-af4b-a5020b56c124	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456 ndc (product): 70518-2767
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	84c6f6bb-8924-4da5-9629-126197195f83	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	AvKARE	339a10c4-e442-de9e-e063-6294a90a6208	2025-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	NuCare Pharmaceuticals, Inc.	2b9ae8ff-f2bc-ccef-e063-6294a90a76da	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Proficient Rx LP	ce06afcb-4e6c-4b78-8bad-9909c8fffa52	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090456 application number: ANDA090456

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7078	Mycophenolate mofetil	Mycophenolate mofetil	Major Pharmaceuticals	ANDA	Current
0904-7078	Mycophenolate mofetil	Mycophenolate mofetil	Major Pharmaceuticals	ANDA	Current
23155-836	Mycophenolate mofetil	Mycophenolate mofetil	Avet Pharmaceuticals Inc	ANDA	Current
50090-2246	Mycophenolate mofetil	Mycophenolate mofetil	A-S Medication Solutions	ANDA	Current
55154-3571	Mycophenolate mofetil	Mycophenolate mofetil	Cardinal Health 107, LLC	ANDA	Current
60687-438	Mycophenolate mofetil	Mycophenolate Mofetil	American Health Packaging	ANDA	Current
60687-438	Mycophenolate mofetil	Mycophenolate Mofetil	American Health Packaging	ANDA	Current
60687-438	Mycophenolate mofetil	Mycophenolate Mofetil	American Health Packaging	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Shasun Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-725	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
70518-2767	Mycophenolate mofetil	Mycophenolate mofetil	REMEDYREPACK INC.	ANDA	Current
70518-2767	Mycophenolate mofetil	Mycophenolate mofetil	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44551	ORIG	2015-07-02