Application 076901

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRTAZAPINE	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No
002	MIRTAZAPINE	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	No	No
003	MIRTAZAPINE	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	45MG	No	No

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	Approval date
A076901-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28
A076901-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28
A076901-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076901-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076901-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076901-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2005-06-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076901-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076901-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076901-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076901-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076901-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076901-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076901-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076901-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076901-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076901-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076901-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076901-003	AB	1	`ea99ee380514…`

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 3 of 5 · 92 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	d0cda063-00c5-0921-ee39-d4de1381f91a	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	f86f1175-806f-4416-af86-b1e28def8244	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	55c5905c-6cb8-4ed4-8e69-97f733ca91b5	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	356eb045-6347-49cc-818e-65b1cdff8f4e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	df06ea51-a962-49d0-a449-137e2220ce7e	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	AvKARE	e5478a6a-a29a-9f61-e053-2995a90a11d0	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Coupler LLC	3eed8213-a240-fc4b-e063-6294a90a3b05	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Rising Pharma Holdings, Inc.	58e9b4c6-531f-49c4-a640-6953e70892fe	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Rising Pharma Holdings, Inc.	73b7bbd9-7dba-4559-890f-3f8dd821e215	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aurolife Pharma LLC	aa05d606-29fd-443e-802b-1d65584d6bb1	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	5127517f-b8d0-4af1-8a2f-5225719600bc	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
REMERONSOLTAB	MIRTAZAPINE	Organon LLC	98ad1917-a094-44f5-a28f-a64a8cfcd887	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Mylan Institutional Inc.	6837b69b-2f86-42cf-b48d-b4a3c7b5413f	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aurobindo Pharma Limited	a4c012f0-50b6-42fb-9f06-a14632f23f2e	2025-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Major Pharmaceuticals	a80463be-f2d2-4074-9bd8-5e52b0832b3a	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aurobindo Pharma Limited	3a8a4490-9243-4201-944d-cea27d3d69f5	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	ATLANTIC BIOLOGICALS CORP.	e6e5cbf7-a958-4ef8-abcc-a7491edb9520	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Viona Pharmaceuticals Inc.	ed491abe-9412-428b-8e24-57242862c99a	2025-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Direct_Rx	3699b988-6d9a-dcc1-e063-6394a90ab38d	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	AvKARE	35922615-7619-3852-e063-6394a90a2e55	2025-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44325	ORIG	2005-08-01