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 4 of 5 · 92 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	NorthStar Rx LLC	979eec8b-1bf4-466b-812e-85a111ce1cb5	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	McKesson Corporation dba SKY Packaging	40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	American Health Packaging	3b7a5f44-8da6-4196-bb5d-8d2770af1b3a	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Advanced Rx Pharmacy of Tennessee, LLC	f8c383c1-d1b3-ceaa-e053-6294a90a6053	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	3bb242b0-42ed-471a-b3c4-5ded1e292e80	2024-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	c47428e5-4717-4471-9231-ec8b5438205a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	20eafce1-50cd-0d9c-e063-6394a90ad6fe	2024-09-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	8c03eb2b-6aed-40a1-a424-67ac1ab6085d	2024-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	ecf7826c-c583-4836-9b00-bf9e4b51a144	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	1e0006b6-9405-95a7-e063-6294a90aa277	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	ac976282-fb68-4db0-912a-28f075b0716c	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	NuCare Pharmaceuticals,Inc.	8e839bb2-2f67-f224-e053-2a95a90ae5d8	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Golden State Medical Supply, Inc.	a6a5949f-5ebf-f37d-e053-2995a90adae5	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e	2023-10-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	NCS HealthCare of KY, LLC dba Vangard Labs	70439462-b632-4d21-8067-560162db3137	2023-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1ba111d1-cf92-4cd9-afcb-3bebd1bacd46	2023-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	SQUARE PHARMACEUTICALS LIMITED	83093852-d212-408e-98fd-33f4603a9d65	2023-07-02		Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	faba9bfd-6725-4917-ab48-24e58b397eb4	2023-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	50ccc34a-4b89-4b07-b153-6c71c6924db1	2023-06-06	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