Application 076307

Type: ANDA
Sponsor: ACTAVIS LABS FL 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
A076307-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17
A076307-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17
A076307-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28

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	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076307-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076307-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	2006-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076307-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	2003-12-17	`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 5 · 92 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	ANI Pharmaceuticals, Inc.	bb134141-6069-4b86-abac-7783bf5df60d	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Coupler LLC	51269807-2b5a-e7aa-e063-6394a90ab657	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Coupler LLC	50718832-88fb-dec1-e063-6294a90ae468	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
mirtazapine	MIRTAZAPINE	Camber Pharmaceuticals, Inc.	b4b9b66e-87a1-4dbb-9eaf-71221bcb2265	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Safecor Health LLC	6d2ff278-0c80-4373-b77d-b5f186c4b991	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	552e2261-53db-4a27-b277-f7b62c3ea2ed	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	f54718d1-3ef7-4472-9e97-90e5fd30db4d	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	6b6e946c-54b5-40e3-918f-9cc29f04cd9a	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	81d9e47e-ae81-4755-a5ee-546a038fadb4	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	7727fe84-f6cc-4b31-bc00-1ecf741ad361	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	e708e8bb-9b13-44d9-96f5-fd73a893a987	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	A-S Medication Solutions	44779383-3ddb-41df-8766-da5d7bef385e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Direct_Rx	dea8c09a-b759-1da7-e053-2a95a90a3346	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	d1b59d87-8442-4c15-8bb9-e39b198d8677	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	c2b38cc5-7738-44fa-9bef-89a18a1039b2	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1cc1a159-11ec-4040-817b-d57fa827a773	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	1fb26f9b-b075-471d-8cc3-fa39246ec2e4	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	beaa0678-e4b9-4241-8b08-e69e2e49530f	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	bd532a25-cfde-4c7d-8015-ba40609fb95c	2025-11-17	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1653	Mirtazapine	Mirtazapine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1653	Mirtazapine	Mirtazapine	Impax Generics	ANDA	Current
0115-1654	Mirtazapine	Mirtazapine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1654	Mirtazapine	Mirtazapine	Impax Generics	ANDA	Current
0115-1656	Mirtazapine	Mirtazapine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1656	Mirtazapine	Mirtazapine	Impax Generics	ANDA	Current
0591-2470	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
71335-0951	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
71335-0951	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23815	ORIG	2005-08-01