Application 022036

Type: NDA
Sponsor: CURRAX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SILENOR	DOXEPIN HYDROCHLORIDE	TABLET;ORAL	EQ 3MG BASE	Yes	No
002	SILENOR	DOXEPIN HYDROCHLORIDE	TABLET;ORAL	EQ 6MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022036-001	SILENOR	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17
N022036-002	SILENOR	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022036-001	AB
N022036-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022036-001	10238620	2027-05-18	U-620		2019-04-08
N022036-001	10653662	2027-05-18	U-620		2020-06-15
N022036-001	12083090	2027-05-18	U-620		2024-10-10
N022036-001	9486437	2027-05-18	U-620		2016-12-02
N022036-001	9861607	2027-05-18	U-620		2018-01-24
N022036-001	10653660	2027-07-20	U-620		2020-06-15
N022036-001	11110074	2027-07-20	U-620		2021-09-22
N022036-001	9572814	2027-07-20	U-620		2017-03-21
N022036-001	7915307	2027-08-24	U-620
N022036-001	11234954	2028-01-18	U-620		2022-02-28
N022036-001	10548871	2028-04-11	U-620		2020-02-28
N022036-001	11096920	2028-04-11	U-620		2021-09-22
N022036-001	9907780	2028-04-11		Drug product	2018-03-26
N022036-001	9107898	2028-05-01	U-620		2015-09-09
N022036-001	9532971	2029-06-01		Drug product	2017-01-13
N022036-001	8513299	2030-09-07	U-620		2013-09-20
N022036-002	10238620	2027-05-18	U-620		2019-04-08
N022036-002	10653662	2027-05-18	U-620		2020-06-15
N022036-002	12083090	2027-05-18	U-620		2024-10-10
N022036-002	9486437	2027-05-18	U-620		2016-12-02
N022036-002	9861607	2027-05-18	U-620		2018-01-24
N022036-002	10653660	2027-07-20	U-620		2020-06-15
N022036-002	11110074	2027-07-20	U-620		2021-09-22
N022036-002	9572814	2027-07-20	U-620		2017-03-21
N022036-002	7915307	2027-08-24	U-620
N022036-002	11234954	2028-01-18	U-620		2022-02-28
N022036-002	10548871	2028-04-11	U-620		2020-02-28
N022036-002	11096920	2028-04-11	U-620		2021-09-22
N022036-002	9907780	2028-04-11		Drug product	2018-03-26
N022036-002	9107898	2028-05-01	U-620		2015-09-09
N022036-002	9532971	2029-06-01		Drug product	2017-01-13
N022036-002	8513299	2030-09-07	U-620

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 3 · 82 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	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL		RLD	2010-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL		RLD, RS	2010-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022036-001	SILENOR	EQ 3MG BASE	TABLET / ORAL	AB	RLD	2010-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022036-002	SILENOR	EQ 6MG BASE	TABLET / ORAL	AB	RLD, RS	2010-03-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	N022036-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022036-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022036-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022036-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022036-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022036-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022036-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022036-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022036-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022036-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022036-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022036-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022036-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022036-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022036-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022036-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022036-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022036-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022036-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022036-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022036-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022036-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022036-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022036-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022036-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022036-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022036-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,184 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022036-001	10238620	2027-05-18	U-620		2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	10653662	2027-05-18	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	12083090	2027-05-18	U-620		2024-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9486437	2027-05-18	U-620		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9861607	2027-05-18	U-620		2018-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	10653660	2027-07-20	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	11110074	2027-07-20	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9572814	2027-07-20	U-620		2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	7915307	2027-08-24	U-620			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	11234954	2028-01-18	U-620		2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	10548871	2028-04-11	U-620		2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	11096920	2028-04-11	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9907780	2028-04-11		Drug product	2018-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9107898	2028-05-01	U-620		2015-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	9532971	2029-06-01		Drug product	2017-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-001	8513299	2030-09-07	U-620		2013-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10238620	2027-05-18	U-620		2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10653662	2027-05-18	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	12083090	2027-05-18	U-620		2024-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9486437	2027-05-18	U-620		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9861607	2027-05-18	U-620		2018-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10653660	2027-07-20	U-620		2020-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	11110074	2027-07-20	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9572814	2027-07-20	U-620		2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	7915307	2027-08-24	U-620			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	11234954	2028-01-18	U-620		2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	10548871	2028-04-11	U-620		2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	11096920	2028-04-11	U-620		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9907780	2028-04-11		Drug product	2018-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9107898	2028-05-01	U-620		2015-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	9532971	2029-06-01		Drug product	2017-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022036-002	8513299	2030-09-07	U-620			`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	10238620	2027-05-18	U-620		2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	10653662	2027-05-18	U-620		2020-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	12083090	2027-05-18	U-620		2024-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	9486437	2027-05-18	U-620		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	9861607	2027-05-18	U-620		2018-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	10653660	2027-07-20	U-620		2020-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	11110074	2027-07-20	U-620		2021-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022036-001	9572814	2027-07-20	U-620		2017-03-21	`31067a03dcf5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Silenor	DOXEPIN HYDROCHLORIDE	Currax Pharmaceuticals LLC	1bec1223-5239-4eb6-a9e8-62444106d2c0	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022036 application number: NDA022036 ndc (product): 42847-106 ndc (product): 42847-103
doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	5b4dba99-6b66-4091-94f1-bf5f021c688a	2022-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022036 application number: NDA022036 ndc (product): 44183-103 ndc (product): 44183-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4810	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4810	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4810	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4811	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4811	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4811	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
42847-103	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-103	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-103	Silenor	doxepin hydrochloride	Pernix Therapeutics, LLC	NDA	Current
42847-103	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-103	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-106	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-106	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-106	Silenor	doxepin hydrochloride	Pernix Therapeutics, LLC	NDA	Current
42847-106	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
42847-106	Silenor	doxepin hydrochloride	Currax Pharmaceuticals LLC	NDA	Current
44183-103	doxepin hydrochloride	doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	NDA AUTHORIZED GENERIC	Current
44183-103	doxepin hydrochloride	doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	NDA AUTHORIZED GENERIC	Current
44183-103	doxepin hydrochloride	doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	NDA AUTHORIZED GENERIC	Current
44183-106	doxepin hydrochloride	doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	NDA AUTHORIZED GENERIC	Current
44183-106	doxepin hydrochloride	doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	NDA AUTHORIZED GENERIC	Current
44183-106	doxepin hydrochloride	doxepin hydrochloride	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65125	SUPPL	2020-11-02
65086	SUPPL	2020-10-30
29119	SUPPL	2012-01-20
44670	ORIG	2011-02-11
21914	ORIG	2011-02-11
23341	ORIG	2010-03-31
29118	ORIG	2010-03-22
38116	ORIG	2010-03-18