Application 076119

Type: ANDA
Sponsor: TEVA

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 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	TE codes	Approval date
A076119-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24
A076119-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24
A076119-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076119-001	AB
A076119-002	AB
A076119-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076119-002	MIRTAZAPINE	30MG	TABLET / ORAL	AB	2003-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076119-003	MIRTAZAPINE	45MG	TABLET / ORAL	AB	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076119-001	MIRTAZAPINE	15MG	TABLET / ORAL	AB	2003-01-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076119-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076119-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076119-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076119-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076119-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076119-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076119-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076119-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076119-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076119-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076119-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076119-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076119-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076119-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076119-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076119-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076119-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076119-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076119-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076119-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076119-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076119-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076119-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076119-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076119-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076119-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076119-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076119-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076119-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076119-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076119-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076119-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076119-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076119-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076119-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076119-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076119-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076119-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076119-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076119-001	AB	1	`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 5 of 5 · 92 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Prasco Laboratories	8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Mylan Pharmaceuticals Inc.	711aa80b-8fc6-49e6-9494-3db31d9b53a4	2022-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	3b516a33-b164-4e4f-bc18-e9d1e591323a	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	a2f01ffd-fd48-499b-9126-8eb9048a5722	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Sun Pharmaceutical Industries, Inc.	f23631be-c7ae-46e9-b771-a70be17bc9f0	2021-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	500dbfbe-2a00-496d-9e44-6e59d2c68ea2	2021-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Proficient Rx LP	a96e0d95-1a7b-4588-923a-2169b5506203	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	93c4ddcf-ca4f-4a46-a7b7-1395fb0885d2	2020-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	NCS HealthCare of KY, Inc dba Vangard Labs	20a724c6-feba-40e7-a35a-8a37de2e0136	2019-03-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	3bda4994-cdf5-47b4-aebc-7297347334e9	2018-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mirtazapine generic name: MIRTAZAPINE
Mirtazapine	MIRTAZAPINE	Aphena Pharma Solutions - Tennessee, LLC	6ad0e695-92ee-4900-b194-a2455473370b	2018-07-31	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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7206	Mirtazapine	Mirtazapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7206	Mirtazapine	Mirtazapine	Teva Pharmaceuticals USA,	ANDA	Current
0093-7207	Mirtazapine	Mirtazapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7207	Mirtazapine	Mirtazapine	Teva Pharmaceuticals USA,	ANDA	Current
0093-7208	Mirtazapine	Mirtazapine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7208	Mirtazapine	Mirtazapine	Teva Pharmaceuticals USA,	ANDA	Current
43063-674	Mirtazapine	Mirtazapine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3083	Mirtazapine	Mirtazapine	A-S Medication Solutions	ANDA	Current
63187-207	Mirtazapine	Mirtazapine	Proficient Rx LP	ANDA	Current
63739-355	Mirtazapine	Mirtazapine	McKesson Corporation	ANDA	Current
63739-356	Mirtazapine	Mirtazapine	McKesson Corporation	ANDA	Current
70518-0901	Mirtazapine	Mirtazapine	REMEDYREPACK INC.	ANDA	Current
70518-0901	Mirtazapine	Mirtazapine	REMEDYREPACK INC.	ANDA	Current
70518-0977	Mirtazapine	Mirtazapine	REMEDYREPACK INC.	ANDA	Current
70518-0977	Mirtazapine	Mirtazapine	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23802	ORIG	2005-08-01
43053	ORIG	2005-07-22
31079	ORIG	2004-06-24