Application 091558

Type: ANDA
Sponsor: APOTEX INC

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 1.

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
A091558-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2012-08-21
A091558-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2014-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091558-001	AB
A091558-002	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 1 of 3 · 82 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	A091558-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091558-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-001	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-002	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091558-001	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091558-002	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091558-001	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-08-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091558-002	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091558-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091558-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091558-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091558-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091558-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091558-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091558-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091558-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091558-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091558-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091558-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091558-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091558-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091558-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091558-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091558-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091558-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091558-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091558-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091558-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091558-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091558-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091558-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091558-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091558-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091558-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091558-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091558-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091558-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolic Acid	MYCOPHENOLIC ACID	American Health Packaging	26b31126-4262-4a15-8a16-234c86763176	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558 ndc (product): 68084-907 ndc (product): 68084-918
Mycophenolic Acid	MYCOPHENOLIC ACID	Major Pharmaceuticals	93763b39-ba21-449b-bdc5-254ba57154e4	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558 ndc (product): 0904-6785 ndc (product): 0904-6786
Mycophenolic Acid	MYCOPHENOLIC ACID	Golden State Medical Supply, Inc.	3a0a6ef4-fb2c-47be-82d7-d2675059c45b	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558 ndc (product): 60429-017 ndc (product): 60429-016
Mycophenolic Acid	MYCOPHENOLIC ACID	Apotex Corp	c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091558 application number: ANDA091558 ndc (product): 60505-2966 ndc (product): 60505-2965

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6785	Mycophenolic Acid	Mycophenolic Acid	Major Pharmaceuticals	ANDA	Current
0904-6785	Mycophenolic Acid	Mycophenolic Acid	Major Pharmaceuticals	ANDA	Current
0904-6786	Mycophenolic Acid	Mycophenolic Acid	Major Pharmaceuticals	ANDA	Current
0904-6786	Mycophenolic Acid	Mycophenolic Acid	Major Pharmaceuticals	ANDA	Current
50268-559	Mycophenolic Acid	Mycophenolic Acid	AvPAK	ANDA	Current
50268-559	Mycophenolic Acid	Mycophenolic Acid	AvPAK	ANDA	Current
50268-559	Mycophenolic Acid	Mycophenolic Acid	AvPAK	ANDA	Current
50268-560	Mycophenolic Acid	Mycophenolic Acid	AvPAK	ANDA	Current
60429-016	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-016	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-016	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply	ANDA	Current
60429-016	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply	ANDA	Current
60429-016	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-016	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-017	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-017	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-017	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply	ANDA	Current
60429-017	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply	ANDA	Current
60429-017	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60429-017	Mycophenolic Acid	Mycophenolic Acid	Golden State Medical Supply, Inc.	ANDA	Current
60505-2965	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2965	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2965	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2965	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2965	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2965	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2966	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2966	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2966	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2966	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2966	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
60505-2966	Mycophenolic Acid	Mycophenolic Acid	Apotex Corp	ANDA	Current
68084-907	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-907	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-907	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-907	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-907	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-918	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-918	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-918	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-918	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
68084-918	Mycophenolic Acid	Mycophenolic Acid	American Health Packaging	ANDA	Current
70518-3218	Mycophenolic Acid	Mycophenolic Acid	REMEDYREPACK INC.	ANDA	Current
70518-3255	Mycophenolic Acid	Mycophenolic Acid	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44557	ORIG	2015-07-02