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 1 of 5 · 91 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Redpharm Drug	58bea4d8-084f-4c30-e063-6394a90a35cb	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	10ea9d83-19c3-4f3b-a1cc-cfc48b42507f	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	89ae6a33-933f-47aa-a2de-2a71cd3f7d44	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
mirtazapine	MIRTAZAPINE	XLCare Pharmaceuticals Inc.	b6b31703-e77d-4d1a-b1ac-da972117e356	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mirtazapine generic name: MIRTAZAPINE
mirtazapine	MIRTAZAPINE	A-S Medication Solutions	222dfdde-6979-4b18-a7eb-ff1ad0a437c1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	577c3ceb-316b-4c93-9b0c-0a4b1b4773e9	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	9135e7db-cba4-4150-a69c-fdf2a347a785	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	c22c4325-4f1a-4d12-8039-d3b1263fa3ad	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	ac3716fd-6971-4a70-ae7b-9f5117f3d880	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Preferred Pharmaceuticals Inc.	2a0689ae-5650-42d1-ac9d-56dd2b467727	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	REMEDYREPACK INC.	aae4c58a-5cbd-45ef-b0f9-32bf28204f15	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	American Health Packaging	82a615a0-e74a-49cb-9a57-ffbb3df604d5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Unit Dose Solutions, Inc.	5539fe37-546b-40a8-e063-6394a90ace1b	2026-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Coupler LLC	538679a1-d474-8e1c-e063-6394a90a15d7	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Coupler LLC	53311d08-9dfa-7bb1-e063-6394a90a6656	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
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

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