Application 211374

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	INJECTABLE;INJECTION	500MG/VIAL	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
A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION			2021-03-05

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.

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	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION	AP	2021-03-05	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211374-001	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		2021-03-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211374-001	AP	1	`87673890dc5c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CellCept	MYCOPHENOLATE MOFETIL	Genentech, Inc.	37241e87-4af4-4dc3-a1aa-ea6f20d8dc40	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Mycophenolate Mofetil	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	BPI Labs LLC	32001417-130d-4c08-8e63-94ba3627ce5f	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70121-1584	mycophenolate mofetil	mycophenolate mofetil	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1584	mycophenolate mofetil	mycophenolate mofetil	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1584	mycophenolate mofetil	mycophenolate mofetil	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1584	mycophenolate mofetil	mycophenolate mofetil	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76500	ORIG	2023-11-07