Application 212087

Type: ANDA
Sponsor: CONCORD BIOTECH LTD

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
A212087-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB		2020-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212087-001	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.

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	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212087-001	MYCOPHENOLATE MOFETIL	500MG	TABLET / ORAL	AB	2020-07-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212087-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212087-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212087-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212087-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212087-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212087-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212087-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212087-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212087-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212087-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212087-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212087-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212087-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212087-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212087-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212087-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212087-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212087-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212087-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212087-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212087-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212087-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212087-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212087-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212087-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212087-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212087-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212087-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212087-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212087-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212087-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212087-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212087-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212087-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212087-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212087-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212087-001	AB	1	`a50c72e98297…`

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
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	Advagen Pharma Limited	a15c26d8-5a27-48ba-a669-8546803d901f	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212087 application number: ANDA212087
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CONCORD BIOTECH LIMITED	64ac00ee-298c-49cf-a91c-78019a0d014d	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212087 application number: ANDA212087 ndc (product): 68254-5003

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68254-5003	Mycophenolate Mofetil	mycophenolate mofetil	CONCORD BIOTECH LIMITED	ANDA	Current
68254-5003	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CONCORD BIOTECH LIMITED	ANDA	Current
68254-5003	Mycophenolate Mofetil	mycophenolate mofetil	CONCORD BIOTECH LIMITED	ANDA	Current
70748-262	Mycophenolate Mofetil	mycophenolate mofetil	Lupin Pharmaceuticals, Inc.	ANDA	Current
70748-262	Mycophenolate Mofetil	mycophenolate mofetil	Lupin Pharmaceuticals, Inc.	ANDA	Current
70748-262	Mycophenolate Mofetil	mycophenolate mofetil	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76496	ORIG	2023-11-07