Application 076312

Type: ANDA
Sponsor: WATSON LABS

Application Products#

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

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

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
A076312-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19
A076312-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19
A076312-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076312-002	MIRTAZAPINE	30MG	TABLET / ORAL	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076312-003	MIRTAZAPINE	45MG	TABLET / ORAL	2003-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076312-001	MIRTAZAPINE	15MG	TABLET / ORAL	2003-06-19	`1e350fbaab3a…`

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 · 91 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	412abf0e-1f96-4d4d-bb56-a23d4699b14c	2025-10-02	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	Apotex Corp.	9675333e-3064-c8cb-a4b4-6c74d9a82f17	2025-09-19	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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-1117	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
0591-1117	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
0591-1118	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
0591-1118	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
0591-1119	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
0591-1119	Mirtazapine	Mirtazapine	Actavis Pharma, Inc.	ANDA	Current
33261-074	Mirtazapine	Mirtazapine	Aidarex Pharmaceuticals LLC	ANDA	Current
42254-086	Mirtazapine	Mirtazapine	Rebel Distributors Corp	ANDA	Current
42254-087	Mirtazapine	Mirtazapine	Rebel Distributors Corp	ANDA	Current
42254-269	Mirtazapine	Mirtazapine	Rebel Distributors Corp	ANDA	Current
50436-3897	Mirtazapine	Mirtazapine	Unit Dose Services	ANDA	Current
64725-1117	Mirtazapine	Mirtazapine	TYA Pharmaceuticals	ANDA	Current
70518-0101	Mirtazapine	Mirtazapine	REMEDYREPACK INC.	ANDA	Current
71610-121	Mirtazapine	Mirtazapine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44303	ORIG	2005-08-01