Application 090111

Type: ANDA
Sponsor: VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	250MG	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
A090111-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL			2009-12-22

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	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2009-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090111-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL		2009-12-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090111-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090111-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090111-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090111-001	AB	1	`ea99ee380514…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 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	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
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	A-S Medication Solutions	b4170ad9-67f0-42ea-b694-6b80824a607a	2025-12-18	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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44547	ORIG	2015-07-06