Application 077376

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MIRTAZAPINE	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No
003	MIRTAZAPINE	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	No	No
004	MIRTAZAPINE	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;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	TE codes	Approval date
A077376-002	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08
A077376-003	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08
A077376-004	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077376-002	AB
A077376-003	AB
A077376-004	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 · 126 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
2026-08-18 06:07:40	2026-07	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-003	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-004	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2006-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-002	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2005-12-08	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077376-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077376-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077376-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077376-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077376-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077376-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077376-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077376-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077376-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077376-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077376-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077376-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077376-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077376-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077376-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077376-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077376-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077376-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077376-002	AB	1	`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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	f86f1175-806f-4416-af86-b1e28def8244	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376
Mirtazapine	MIRTAZAPINE	Rising Pharma Holdings, Inc.	73b7bbd9-7dba-4559-890f-3f8dd821e215	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376 ndc (product): 57237-013 ndc (product): 57237-012 ndc (product): 57237-011
Mirtazapine	MIRTAZAPINE	Cardinal Health 107, LLC	5127517f-b8d0-4af1-8a2f-5225719600bc	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376 ndc (product): 55154-8335
Mirtazapine	MIRTAZAPINE	Aurobindo Pharma Limited	3a8a4490-9243-4201-944d-cea27d3d69f5	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077376 application number: ANDA077376 ndc (product): 65862-022 ndc (product): 65862-021 ndc (product): 65862-023

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55154-8335	Mirtazapine	Mirtazapine	Cardinal Health	ANDA	Current
55154-8335	Mirtazapine	Mirtazapine	Cardinal Health	ANDA	Current
55154-8335	Mirtazapine	Mirtazapine	Cardinal Health 107, LLC	ANDA	Current
57237-011	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-011	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-011	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-011	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-011	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-011	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-012	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-012	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-012	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-012	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-012	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-012	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-013	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-013	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-013	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-013	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-013	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
57237-013	Mirtazapine	Mirtazapine	Rising Health, LLC	ANDA	Current
63629-5085	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5086	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5086	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5086	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5275	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5537	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5537	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
63629-5537	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
65862-021	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-021	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-021	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-021	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-021	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-021	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-022	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-022	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-022	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-022	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-022	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-022	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-023	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-023	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-023	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-023	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-023	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
65862-023	Mirtazapine	Mirtazapine	Aurobindo Pharma Limited	ANDA	Current
71335-0717	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
71335-0717	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
71335-0717	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
71335-1534	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current
71335-1534	Mirtazapine	Mirtazapine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44350	ORIG	2006-03-09