Application 050791

Type: NDA
Sponsor: NOVARTIS

Application Products#

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

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
N050791-001	MYFORTIC	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27
N050791-002	MYFORTIC	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050791-001	AB
N050791-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050791-001	MYFORTIC	180MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050791-002	MYFORTIC	360MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050791-001	MYFORTIC	EQ 180MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2004-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050791-002	MYFORTIC	EQ 360MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2004-02-27	`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	N050791-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050791-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050791-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050791-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050791-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050791-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050791-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050791-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050791-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050791-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050791-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050791-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050791-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050791-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050791-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050791-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050791-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050791-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050791-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050791-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050791-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050791-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050791-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050791-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050791-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050791-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050791-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050791-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050791-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050791-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050791-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050791-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050791-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050791-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050791-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050791-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050791-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050791-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050791-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050791-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Myfortic	MYCOPHENOLIC ACID	Novartis Pharmaceuticals Corporation	eed26501-890d-4ff6-88e7-6dbea4726e53	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050791 application number: NDA050791 ndc (product): 0078-0385 ndc (product): 0078-0386

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0385	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0386	Myfortic	mycophenolic acid	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82710	SUPPL	2025-06-30
82704	SUPPL	2025-06-30
79389	SUPPL	2024-08-14
70534	SUPPL	2022-03-16
70533	SUPPL	2022-03-16
70527	SUPPL	2022-03-16
68362	SUPPL	2021-08-13
67159	SUPPL	2021-04-23
66806	SUPPL	2021-03-18
66792	SUPPL	2021-03-17
65941	SUPPL	2021-01-19
62740	SUPPL	2020-04-29
62739	SUPPL	2020-04-29
62735	SUPPL	2020-04-29
56377	SUPPL	2018-11-08
30562	SUPPL	2015-11-16
39341	SUPPL	2015-10-29
8299	SUPPL	2015-10-29
8298	SUPPL	2015-08-12
30561	SUPPL	2013-10-01
8297	SUPPL	2013-10-01
18261	SUPPL	2013-09-30
18260	SUPPL	2013-09-30
39340	SUPPL	2013-05-09
30559	SUPPL	2013-05-07
30554	SUPPL	2012-09-27
24040	ORIG	2012-09-27
30560	SUPPL	2012-06-26
18259	SUPPL	2012-06-26
30558	SUPPL	2010-11-03
18258	SUPPL	2010-10-28
30557	SUPPL	2009-11-09
23425	ORIG	2009-10-16
18257	SUPPL	2009-10-14
30556	SUPPL	2009-07-17
44209	ORIG	2009-07-15
18256	SUPPL	2009-07-14
30555	SUPPL	2009-04-01
18255	SUPPL	2009-01-02
30553	SUPPL	2008-12-19
18254	SUPPL	2008-05-16
30552	SUPPL	2008-05-14
30551	SUPPL	2007-11-08
39339	SUPPL	2007-11-07
22241	ORIG	2005-04-27
30550	ORIG	2004-03-03