Application 091248

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	360MG	No	No
002	MYCOPHENOLIC ACID	MYCOPHENOLIC ACID	TABLET, DELAYED RELEASE;ORAL	180MG	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
A091248-001	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL			2014-01-08
A091248-002	MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL			2014-01-08

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	A091248-001	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091248-002	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL		2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-001	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-002	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091248-001	MYCOPHENOLIC ACID	360MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091248-002	MYCOPHENOLIC ACID	180MG	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091248-001	MYCOPHENOLIC SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091248-002	MYCOPHENOLIC SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-01-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091248-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091248-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091248-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091248-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091248-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091248-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091248-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091248-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091248-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091248-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091248-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091248-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091248-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091248-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091248-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091248-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091248-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091248-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091248-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091248-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091248-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091248-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091248-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091248-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091248-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091248-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091248-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091248-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091248-002	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolic Acid	MYCOPHENILIC ACID	Archis Pharma LLC	30cb1078-929b-4c0f-be1d-49ef352dfab9	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091248 application number: ANDA091248 ndc (product): 72819-156 ndc (product): 72819-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4201	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4201	Mycophenolic Acid	mycophenilic acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4201	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4201	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4201	Mycophenolic Acid	mycophenilic acid	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4201	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4202	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4202	Mycophenolic Acid	mycophenilic acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4202	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4202	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4202	Mycophenolic Acid	mycophenilic acid	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4202	Mycophenolic Acid	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-508	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-508	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-508	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-508	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-509	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-509	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-509	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
51079-509	Mycophenolic Acid	mycophenilic acid	Mylan Institutional Inc.	ANDA	Current
72819-155	Mycophenolic Acid	mycophenilic acid	Archis Pharma LLC	ANDA	Current
72819-156	Mycophenolic Acid	mycophenilic acid	Archis Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24075	ORIG	2015-07-06
9326	ORIG	2014-01-14