Application 075155

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET, EXTENDED RELEASE;ORAL	60MG	No	No
002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No
003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET, EXTENDED RELEASE;ORAL	120MG	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075155-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30
A075155-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13
A075155-003	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075155-001	AB
A075155-002	AB
A075155-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-01-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-003	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-10-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A075155-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075155-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075155-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075155-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075155-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075155-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075155-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075155-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075155-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075155-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075155-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075155-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075155-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075155-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075155-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075155-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075155-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075155-001	AB	1	`301d65b070ca…`

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	ba6120c8-c885-4cfa-b68e-9eee7a3bad6d	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	63dc518f-4f86-4820-98c2-5de8aed09a4b	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	NuCare Pharmaceuticals,Inc.	65935a15-a023-1941-e053-2991aa0a5eb4	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	17525ff2-9ec0-15a1-e063-6394a90ab762	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	441ddd35-6cb8-44d0-8009-1635390ede83	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	0af6c67f-919d-4515-8074-f6c3aaa835b5	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	18cf36bc-e73f-4274-b381-c2f2aa02f57d	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	A-S Medication Solutions	adcca9b8-0505-4bbc-81ab-05efc7407b6b	2024-01-23	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	A-S Medication Solutions	4da5a0ac-574d-48ea-80ba-55344bfefb91	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	A-S Medication Solutions	44a0f691-b826-4580-ab2d-b5d1cc99e283	2023-11-09	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Ingenus Pharmaceuticals, LLC	c950760f-0e32-483f-96f2-eecaf057c0ec	2023-10-27	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	96420729-2bc7-4d03-9c51-f786ea678998	2023-10-26	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	A-S Medication Solutions	5a8164a3-56e2-4b9b-8718-0423b4b4958f	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Aurobindo Pharma Limited	55810c9d-1140-40b8-a297-210a84afc05a	2022-11-11	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Actavis Pharma, Inc.	ae8f74f0-e600-4452-8557-958b603e2709	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Lannett Company, Inc.	bf9e7e35-7707-42a0-88d6-6292fa52bbfa	2020-06-05	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Proficient Rx LP	f871dfa7-219f-4704-8e4d-215caeb7408d	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE

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 · 68 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-575	isosorbide mononitrate	isosorbide mononitrate	Rebel Distributors Corp	ANDA	Current
21695-777	isosorbide mononitrate	isosorbide mononitrate	Rebel Distributors Corp	ANDA	Current
21695-837	isosorbide mononitrate	isosorbide mononitrate	Rebel Distributors Corp	ANDA	Current
43063-313	isosorbide mononitrate	isosorbide mononitrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-313	isosorbide mononitrate	isosorbide mononitrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-313	isosorbide mononitrate	isosorbide mononitrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-313	isosorbide mononitrate	isosorbide mononitrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-313	isosorbide mononitrate	isosorbide mononitrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-917	isosorbide mononitrate	isosorbide mononitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-917	isosorbide mononitrate	isosorbide mononitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0787	isosorbide mononitrate	isosorbide mononitrate	A-S Medication Solutions	ANDA	Current
50090-2077	isosorbide mononitrate	isosorbide mononitrate	A-S Medication Solutions	ANDA	Current
50268-451	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-451	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-451	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-452	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-452	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-452	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-453	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-453	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50268-453	isosorbide mononitrate	isosorbide mononitrate	AvPAK	ANDA	Current
50436-3944	isosorbide mononitrate	isosorbide mononitrate	Unit Dose Services	ANDA	Current
55154-4785	isosorbide mononitrate	isosorbide mononitrate	Cardinal Health	ANDA	Current
55154-4785	isosorbide mononitrate	isosorbide mononitrate	Cardinal Health	ANDA	Current
55154-4785	isosorbide mononitrate	isosorbide mononitrate	Cardinal Health	ANDA	Current
55154-4786	isosorbide mononitrate	isosorbide mononitrate	Cardinal Health	ANDA	Current
55154-4786	isosorbide mononitrate	isosorbide mononitrate	Cardinal Health	ANDA	Current
55154-4786	isosorbide mononitrate	isosorbide mononitrate	Cardinal Health	ANDA	Current
55700-123	isosorbide mononitrate	isosorbide mononitrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
62175-119	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	ANDA	Current
62175-119	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-119	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-119	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-128	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	ANDA	Current
62175-128	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-128	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-128	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-129	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc..	ANDA	Current
62175-129	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-129	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
62175-129	isosorbide mononitrate	isosorbide mononitrate	Lannett Company, Inc.	ANDA	Current
63629-1424	isosorbide mononitrate	isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current
63629-1424	isosorbide mononitrate	isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current
63629-1424	isosorbide mononitrate	isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current
63629-1823	isosorbide mononitrate	isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current
63629-1823	isosorbide mononitrate	isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current
67544-224	isosorbide mononitrate	isosorbide mononitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-224	isosorbide mononitrate	isosorbide mononitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-236	isosorbide mononitrate	isosorbide mononitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-236	isosorbide mononitrate	isosorbide mononitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-1926	isosorbide mononitrate	isosorbide mononitrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3266	isosorbide mononitrate	isosorbide mononitrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68084-591	isosorbide mononitrate	isosorbide mononitrate	American Health Packaging	ANDA	Current
68084-591	Isosorbide Mononitrate	Isosorbide Mononitrate	American Health Packaging	ANDA	Current
68084-591	Isosorbide Mononitrate	Isosorbide Mononitrate	American Health Packaging	ANDA	Current
68084-591	Isosorbide Mononitrate	Isosorbide Mononitrate	American Health Packaging	ANDA	Current
68084-592	isosorbide mononitrate	isosorbide mononitrate	American Health Packaging	ANDA	Current
68084-592	Isosorbide Mononitrate	Isosorbide Mononitrate	American Health Packaging	ANDA	Current
68084-592	Isosorbide Mononitrate	Isosorbide Mononitrate	American Health Packaging	ANDA	Current
68084-592	Isosorbide Mononitrate	Isosorbide Mononitrate	American Health Packaging	ANDA	Current
68151-1420	isosorbide mononitrate	isosorbide mononitrate	Carilion Materials Management	ANDA	Current
68788-6863	isosorbide mononitrate	isosorbide mononitrate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0009	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2201	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2201	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2201	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-3132	isosorbide mononitrate	isosorbide mononitrate	REMEDYREPACK INC.	ANDA	Current
70934-573	isosorbide mononitrate	isosorbide mononitrate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39459	SUPPL	2014-10-24
8543	SUPPL	2014-10-24
8542	ORIG	1998-10-30