Application 021876

Type: NDA
Sponsor: DUCHESNAY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLEGIS	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	TABLET, DELAYED RELEASE;ORAL	10MG;10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021876-001	DICLEGIS	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021876-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N021876-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021876-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021876-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021876-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021876-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021876-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021876-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021876-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021876-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021876-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021876-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021876-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021876-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021876-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021876-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021876-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021876-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021876-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021876-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021876-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021876-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021876-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021876-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021876-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021876-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021876-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021876-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021876-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021876-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021876-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021876-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021876-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021876-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021876-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021876-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021876-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021876-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021876-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021876-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021876-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`ea99ee380514…`

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
DICLEGIS	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	Duchesnay USA, Inc.	8bde08f6-e8bd-4e90-baa7-82e01876a86a	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021876 application number: NDA021876 ndc (product): 55494-100
Doxylamine succinate and pyridoxine hydrochloride	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	Analog Pharma	76d10d65-0279-4e86-8104-cade4343f839	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021876 application number: NDA021876 ndc (product): 70505-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride	Duchesnay USA, Inc.	NDA	Current
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride	Duchesnay USA, Inc.	NDA	Current
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride	Duchesnay USA, Inc.	NDA	Current
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride	Duchesnay USA, Inc.	NDA	Current
55494-100	DICLEGIS	doxylamine succinate and pyridoxine hydrochloride	Duchesnay USA, Inc.	NDA	Current
63629-8358	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8358	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Analog Pharma	NDA AUTHORIZED GENERIC	Current
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Analog Pharma	NDA AUTHORIZED GENERIC	Current
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Analog Pharma	NDA AUTHORIZED GENERIC	Current
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Analog Pharma	NDA AUTHORIZED GENERIC	Current
70505-100	Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate and pyridoxine hydrochloride	Analog Pharma	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72519	SUPPL	2022-11-01
72516	SUPPL	2022-11-01
54672	SUPPL	2018-06-21
54635	SUPPL	2018-06-21
28756	SUPPL	2014-12-17
44656	ORIG	2014-03-25
21853	ORIG	2014-03-25
16503	SUPPL	2013-09-30
16502	ORIG	2013-04-16
6359	ORIG	2013-04-10