Application 020859

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SONATA	ZALEPLON	CAPSULE;ORAL	5MG	Yes	No
002	SONATA	ZALEPLON	CAPSULE;ORAL	10MG	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
N020859-001	SONATA	ZALEPLON	5MG	CAPSULE / ORAL		RLD	1999-08-13
N020859-002	SONATA	ZALEPLON	10MG	CAPSULE / ORAL		RLD	1999-08-13

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	N020859-001	SONATA	5MG	CAPSULE / ORAL		RLD	1999-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020859-002	SONATA	10MG	CAPSULE / ORAL		RLD	1999-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020859-001	SONATA	5MG	CAPSULE / ORAL		RLD	1999-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020859-002	SONATA	10MG	CAPSULE / ORAL		RLD	1999-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020859-001	SONATA	5MG	CAPSULE / ORAL	AB	RLD	1999-08-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020859-002	SONATA	10MG	CAPSULE / ORAL	AB	RLD, RS	1999-08-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N020859-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020859-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020859-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020859-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020859-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020859-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020859-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020859-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020859-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020859-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020859-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020859-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020859-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020859-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020859-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020859-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020859-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020859-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020859-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020859-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020859-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020859-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020859-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020859-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020859-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020859-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020859-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020859-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020859-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020859-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020859-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020859-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020859-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020859-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020859-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020859-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020859-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020859-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020859-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020859-002	AB	1	`5aa47cf7b7d7…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zaleplon	ZALEPLON	PD-Rx Pharmaceuticals, Inc.	a1277ef5-6072-43ff-a6ce-0a7cea58b7cb	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
zaleplon	ZALEPLON	PD-Rx Pharmaceuticals, Inc.	2cc7adee-2c4c-4fed-9914-545e70dba773	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
ZALEPLON	ZALEPLON	PD-Rx Pharmaceuticals, Inc.	9c83b71e-8344-4c77-b7f6-a9c862f9e7dd	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
zaleplon	ZALEPLON	Preferred Pharmaceuticals Inc.	b0476859-07af-47f1-aec7-61aea0d99d24	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
Zaleplon	ZALEPLON	Preferred Pharmaceuticals Inc.	d58138d1-3378-482c-a401-958dabe1be7d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
Zaleplon	ZALEPLON	Bryant Ranch Prepack	517953c8-22ad-41af-a869-b7e4e5b291ae	2024-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
ZALEPLON	ZALEPLON	Bryant Ranch Prepack	bec67c5d-9f8f-4490-a0b4-9b7905b565f1	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
ZALEPLON	ZALEPLON	Rising Pharma Holdings, Inc.	cff46def-c452-49bb-abea-480de8f432bd	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
ZALEPLON	ZALEPLON	Aurobindo Pharma Limited	e092f3ca-bf44-4568-a72c-3fb2cf5b192b	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
Zaleplon	ZALEPLON	Bionpharma Inc.	53103d2f-4453-49a8-9e36-888d919879f6	2024-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
zaleplon	ZALEPLON	A-S Medication Solutions	8276a418-6a4c-4b81-8170-2d3838576c6d	2024-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
zaleplon	ZALEPLON	Bryant Ranch Prepack	d8c88122-ce04-4caf-bd4d-0a4368ea89ad	2023-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
zaleplon	ZALEPLON	Bryant Ranch Prepack	b8032b14-5068-19d5-e063-839ed25d7200	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
zaleplon	ZALEPLON	Unichem Pharmaceuticals (USA), Inc.	57a1a11d-7767-4caf-b98a-75d7561d9165	2021-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON
Zaleplon	ZALEPLON	Hikma Pharmaceuticals USA Inc.	cadd9d75-2139-4fab-94ce-2992e6a55780	2019-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZALEPLON

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-105	ZALEPLON	ZALEPLON	Rebel Distributors Corp.	NDA	Current
21695-376	ZALEPLON	ZALEPLON	Rebel Distributors Corp.	NDA	Current
60793-145	Sonata	zaleplon	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-146	Sonata	zaleplon	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59764	SUPPL	2019-08-20
59763	SUPPL	2019-08-20
59755	SUPPL	2019-08-20
57607	SUPPL	2019-02-14
57487	SUPPL	2019-02-07
57486	SUPPL	2019-02-07
23200	ORIG	2013-04-26
3593	SUPPL	2013-04-24
35522	SUPPL	2013-04-23
3592	SUPPL	2008-01-09
3591	SUPPL	2008-01-09
35521	SUPPL	2007-12-14
13628	SUPPL	2007-12-14
23606	ORIG	2003-12-12
26068	SUPPL	2003-06-08
26067	SUPPL	2003-06-08
3589	SUPPL	2002-06-03
3590	SUPPL	2002-05-31
35520	SUPPL	2001-02-22
3588	SUPPL	2001-02-22
21025	ORIG	2000-07-03
35519	ORIG	1999-08-13
3587	ORIG	1999-08-13