Application 077239

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZALEPLON	ZALEPLON	CAPSULE;ORAL	5MG	No	No
002	ZALEPLON	ZALEPLON	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077239-001	ZALEPLON	ZALEPLON	5MG	CAPSULE / ORAL			2008-06-06
A077239-002	ZALEPLON	ZALEPLON	10MG	CAPSULE / ORAL			2008-06-06

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A077239-001	ZALEPLON	5MG	CAPSULE / ORAL	2008-06-06	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077239-002	ZALEPLON	10MG	CAPSULE / ORAL	2008-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077239-001	ZALEPLON	5MG	CAPSULE / ORAL	2008-06-06	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077239-002	ZALEPLON	10MG	CAPSULE / ORAL	2008-06-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077239-001	ZALEPLON	5MG	CAPSULE / ORAL	2008-06-06	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077239-002	ZALEPLON	10MG	CAPSULE / ORAL	2008-06-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077239-001	ZALEPLON	5MG	CAPSULE / ORAL	2008-06-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077239-002	ZALEPLON	10MG	CAPSULE / ORAL	2008-06-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077239-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077239-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077239-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077239-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077239-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077239-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077239-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077239-002	AB	1	`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 · 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 brand name: Zaleplon generic name: ZALEPLON
zaleplon	ZALEPLON	PD-Rx Pharmaceuticals, Inc.	2cc7adee-2c4c-4fed-9914-545e70dba773	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: zaleplon generic name: ZALEPLON
ZALEPLON	ZALEPLON	PD-Rx Pharmaceuticals, Inc.	9c83b71e-8344-4c77-b7f6-a9c862f9e7dd	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZALEPLON generic name: ZALEPLON
zaleplon	ZALEPLON	Preferred Pharmaceuticals Inc.	b0476859-07af-47f1-aec7-61aea0d99d24	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: zaleplon generic name: ZALEPLON
Zaleplon	ZALEPLON	Preferred Pharmaceuticals Inc.	d58138d1-3378-482c-a401-958dabe1be7d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zaleplon generic name: ZALEPLON
Zaleplon	ZALEPLON	Bryant Ranch Prepack	517953c8-22ad-41af-a869-b7e4e5b291ae	2024-08-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zaleplon generic name: ZALEPLON
ZALEPLON	ZALEPLON	Bryant Ranch Prepack	bec67c5d-9f8f-4490-a0b4-9b7905b565f1	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZALEPLON generic name: ZALEPLON
ZALEPLON	ZALEPLON	Rising Pharma Holdings, Inc.	cff46def-c452-49bb-abea-480de8f432bd	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZALEPLON generic name: ZALEPLON
ZALEPLON	ZALEPLON	Aurobindo Pharma Limited	e092f3ca-bf44-4568-a72c-3fb2cf5b192b	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ZALEPLON generic name: ZALEPLON
Zaleplon	ZALEPLON	Bionpharma Inc.	53103d2f-4453-49a8-9e36-888d919879f6	2024-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zaleplon generic name: ZALEPLON
zaleplon	ZALEPLON	A-S Medication Solutions	8276a418-6a4c-4b81-8170-2d3838576c6d	2024-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: zaleplon generic name: ZALEPLON
zaleplon	ZALEPLON	Bryant Ranch Prepack	d8c88122-ce04-4caf-bd4d-0a4368ea89ad	2023-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: zaleplon generic name: ZALEPLON
zaleplon	ZALEPLON	Bryant Ranch Prepack	b8032b14-5068-19d5-e063-839ed25d7200	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: zaleplon generic name: ZALEPLON
zaleplon	ZALEPLON	Unichem Pharmaceuticals (USA), Inc.	57a1a11d-7767-4caf-b98a-75d7561d9165	2021-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: zaleplon generic name: ZALEPLON
Zaleplon	ZALEPLON	Hikma Pharmaceuticals USA Inc.	cadd9d75-2139-4fab-94ce-2992e6a55780	2019-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Zaleplon generic name: ZALEPLON

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5268	Zaleplon	Zaleplon	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5268	Zaleplon	Zaleplon	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5269	Zaleplon	Zaleplon	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5269	Zaleplon	Zaleplon	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-3420	Zaleplon	Zaleplon	A-S Medication Solutions	ANDA	Current
50436-1006	Zaleplon	Zaleplon	Unit Dose Services	ANDA	Current
55700-190	Zaleplon	Zaleplon	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
66336-056	Zaleplon	Zaleplon	Dispensing Solutions, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18458	ORIG	2008-07-14
23864	ORIG	2008-07-01
31209	ORIG	2008-06-10