Application 202555

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	180MG	No	No
002	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	360MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202555-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2017-08-23
A202555-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2017-08-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202555-001	AB
A202555-002	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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202555-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202555-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202555-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202555-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2017-08-23	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202555-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202555-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202555-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202555-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202555-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202555-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202555-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202555-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202555-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202555-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202555-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202555-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202555-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202555-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202555-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202555-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202555-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202555-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202555-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202555-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202555-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202555-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202555-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202555-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202555-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202555-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202555-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202555-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202555-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202555-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202555-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202555-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202555-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202555-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202555-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202555-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202555-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202555-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202555-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202555-002	AB	1	`74a2ff9319b5…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	REMEDYREPACK INC.	bc98d9a1-b4e3-4085-a8ba-d3313246658a	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLIC ACID generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	Apotex Corp	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	Biocon Pharma Inc.	8516e135-5cc0-ef2d-6dad-0f9f841bb27b	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
Myfortic	MYCOPHENOLIC ACID	Novartis Pharmaceuticals Corporation	eed26501-890d-4ff6-88e7-6dbea4726e53	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	American Health Packaging	26b31126-4262-4a15-8a16-234c86763176	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	Major Pharmaceuticals	6b170816-6e5c-400c-b97b-82bbbb7d4925	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLIC ACID generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	Major Pharmaceuticals	93763b39-ba21-449b-bdc5-254ba57154e4	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	Slate Run Pharmaceuticals, LLC	c1ce92ef-4102-1487-e053-2995a90ac521	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	Ascend Laboratories, LLC	8617bd03-6da7-48ca-b430-6dfc38f19e2b	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLIC ACID generic name: MYCOPHENOLIC ACID
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	Ascend Laboratories, LLC	2d9975e1-baee-4b0c-83de-8a0a92c5d075	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLIC ACID generic name: MYCOPHENOLIC ACID
mycophenolic acid	MYCOPHENOLIC ACID	Stellon Biotech Inc.	4b153bb3-fb7a-472d-b73e-e630e50c5633	2026-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolic acid generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENILIC ACID	Archis Pharma LLC	30cb1078-929b-4c0f-be1d-49ef352dfab9	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid
Mycophenolic Acid	MYCOPHENOLIC ACID	Golden State Medical Supply, Inc.	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	Biocon Pharma Inc.	7f8d259a-9880-bb8b-2738-b3c6c1edf152	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
mycophenolic acid	MYCOPHENOLIC ACID	Advagen Pharma Limited	a2c1a135-67e7-4052-bbb9-b6135d45ff75	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolic acid generic name: MYCOPHENOLIC ACID
mycophenolic acid	MYCOPHENOLIC ACID	CONCORD BIOTECH LIMITED	a374549e-8afd-48fe-ae3f-368984689a2a	2025-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mycophenolic acid generic name: MYCOPHENOLIC ACID
Mycophenolic Acid	MYCOPHENOLIC ACID	Novugen Pharma (USA) LLC.	cbc3e916-09e2-4e6e-9e5e-98375f5e6d41	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mycophenolic Acid generic name: MYCOPHENOLIC ACID
MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	A-S Medication Solutions	8b73dc87-c611-4bcb-8852-532eb388cb2e	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MYCOPHENOLIC ACID generic name: MYCOPHENOLIC ACID

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-189	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-189	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-189	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-189	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-261	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-261	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-261	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current
16729-261	Mycophenolic Acid	Mycophenolic Acid	Accord Healthcare Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76493	ORIG	2023-11-07