Application 020215

Type: NDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONOKET	ISOSORBIDE MONONITRATE	TABLET;ORAL	20MG	Yes	Yes
002	MONOKET	ISOSORBIDE MONONITRATE	TABLET;ORAL	10MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020215-001	MONOKET	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30
N020215-002	MONOKET	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	RLD	1993-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020215-001	AB
N020215-002	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 · 84 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
2026-08-18 06:07:40	2026-07	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020215-001	MONOKET	20MG	TABLET / ORAL	AB	RLD, RS	1993-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020215-002	MONOKET	10MG	TABLET / ORAL	AB	RLD	1993-06-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020215-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020215-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020215-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020215-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020215-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020215-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020215-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020215-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020215-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020215-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020215-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020215-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020215-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020215-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020215-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020215-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020215-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020215-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020215-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020215-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020215-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020215-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020215-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020215-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020215-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020215-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020215-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020215-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020215-002	AB	1	`bb7c543d1eb4…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	3e0e013f-6887-fa72-e063-6294a90a18ca	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	3dffc84e-93e4-0005-e063-6294a90aa9ca	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215
isosorbide mononitrate	ISOSORBIDE MONONITRATE	OMNIVIUM PHARMACEUTICALS LLC.	cdf01e14-778b-4b3f-8372-1c18f266fb98	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Lannett Company, Inc.	bf9e7e35-7707-42a0-88d6-6292fa52bbfa	2020-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215 ndc (product): 62175-107 ndc (product): 62175-106
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Proficient Rx LP	f871dfa7-219f-4704-8e4d-215caeb7408d	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020215 application number: NDA020215 ndc (product): 63187-900

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62175-106	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-106	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-106	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	NDA AUTHORIZED GENERIC	Current
62175-107	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-107	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
62175-107	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	NDA AUTHORIZED GENERIC	Current
62175-361	Monoket	isosorbide mononitrate	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-361	Monoket	isosorbide mononitrate	Lannett Company, Inc.	NDA	Current
62175-362	Monoket	isosorbide mononitrate	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-362	Monoket	isosorbide mononitrate	Lannett Company, Inc.	NDA	Current
63187-900	isosorbide mononitrate	isosorbide mononitrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-900	isosorbide mononitrate	isosorbide mononitrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
68151-0314	isosorbide mononitrate	isosorbide mononitrate	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2000	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2206	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2206	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2206	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70071	SUPPL	2022-02-04
34377	SUPPL	2014-10-03
2173	SUPPL	2014-10-03