Application 021208

Type: NDA
Sponsor: ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REMERON SOLTAB	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	Yes	Yes
002	REMERON SOLTAB	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG	Yes	No
003	REMERON SOLTAB	MIRTAZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	45MG	Yes	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	RLD / RS	Approval date
N021208-001	REMERON SOLTAB	MIRTAZAPINE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12
N021208-002	REMERON SOLTAB	MIRTAZAPINE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12
N021208-003	REMERON SOLTAB	MIRTAZAPINE	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021208-001	AB
N021208-002	AB
N021208-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-002	REMERON SOLTAB	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-003	REMERON SOLTAB	45MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021208-001	REMERON SOLTAB	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-01-12	`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	N021208-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021208-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021208-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021208-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021208-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021208-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021208-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021208-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021208-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021208-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021208-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021208-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021208-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021208-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021208-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021208-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021208-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REMERONSOLTAB	MIRTAZAPINE	Organon LLC	98ad1917-a094-44f5-a28f-a64a8cfcd887	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021208 application number: NDA021208 ndc (product): 78206-159 ndc (product): 78206-156 ndc (product): 78206-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0052-0106	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0106	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0106	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0106	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0106	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0108	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0108	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0108	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0108	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0108	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0110	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0110	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0110	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0110	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
0052-0110	REMERONSOLTAB	MIRTAZAPINE	Organon USA Inc.	NDA	Current
78206-156	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-156	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-156	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-158	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-158	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-158	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-159	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-159	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current
78206-159	REMERONSOLTAB	MIRTAZAPINE	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69362	SUPPL	2021-11-19
69361	SUPPL	2021-11-19
62783	SUPPL	2020-04-30
62782	SUPPL	2020-04-30
62781	SUPPL	2020-04-30
62780	SUPPL	2020-04-30
62766	SUPPL	2020-04-30
62765	SUPPL	2020-04-30
62764	SUPPL	2020-04-30
62037	SUPPL	2020-03-04
62035	SUPPL	2020-03-04
59932	SUPPL	2019-09-06
59925	SUPPL	2019-09-06
59924	SUPPL	2019-09-06
14636	SUPPL	2016-08-01
14637	SUPPL	2015-12-31
4643	SUPPL	2015-12-31
36359	SUPPL	2014-07-30
27073	SUPPL	2014-07-23
36358	SUPPL	2012-11-06
4642	SUPPL	2012-11-01
36356	SUPPL	2012-01-26
27071	SUPPL	2012-01-03
36357	SUPPL	2010-05-28
14635	SUPPL	2010-05-28
27072	SUPPL	2010-05-21
4641	SUPPL	2010-05-21
4640	SUPPL	2007-08-02
36355	SUPPL	2007-07-31
23633	ORIG	2005-08-01
27070	SUPPL	2005-01-13
14634	SUPPL	2005-01-13
27069	SUPPL	2004-06-07
27068	SUPPL	2003-07-24
21507	ORIG	2002-04-29
27067	ORIG	2001-01-12
14633	ORIG	2001-01-12