Application 205798

Type: ANDA
Sponsor: ZYDUS PHARMS

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 1.

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
A205798-001	MIRTAZAPINE	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01
A205798-002	MIRTAZAPINE	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01
A205798-003	MIRTAZAPINE	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205798-001	AB
A205798-002	AB
A205798-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-002	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-003	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205798-001	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-06-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205798-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205798-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205798-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205798-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205798-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205798-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205798-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205798-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205798-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205798-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205798-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205798-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205798-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205798-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mirtazapine	MIRTAZAPINE	Viona Pharmaceuticals Inc.	ed491abe-9412-428b-8e24-57242862c99a	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205798 application number: ANDA205798 ndc (product): 72578-104 ndc (product): 72578-105 ndc (product): 72578-103
Mirtazapine	MIRTAZAPINE	Bryant Ranch Prepack	c47428e5-4717-4471-9231-ec8b5438205a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205798 application number: ANDA205798
Mirtazapine	MIRTAZAPINE	SQUARE PHARMACEUTICALS LIMITED	83093852-d212-408e-98fd-33f4603a9d65	2023-07-02		Exact identifier application applno (ANDA): 205798 application number: ANDA205798 ndc (product): 76483-110 ndc (product): 76483-111 ndc (product): 76483-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-676	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-676	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-676	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-676	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-676	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-677	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-677	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-677	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-677	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-677	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-679	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-679	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-679	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-679	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-679	mirtazapine	mirtazapine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1072	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1072	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1072	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1072	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1073	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1073	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1073	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1073	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1074	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1074	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1074	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
70771-1074	mirtazapine	mirtazapine	Cadila Healthcare Limited	ANDA	Current
72578-103	Mirtazapine	Mirtazapine	Viona Pharmaceuticals Inc.	ANDA	Current
72578-104	Mirtazapine	Mirtazapine	Viona Pharmaceuticals Inc.	ANDA	Current
72578-105	Mirtazapine	Mirtazapine	Viona Pharmaceuticals Inc.	ANDA	Current
76483-110	Mirtazapine	Mirtazapine	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current
76483-111	Mirtazapine	Mirtazapine	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current
76483-112	Mirtazapine	Mirtazapine	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current