Application 070156

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXY-SLEEP-AID	DOXYLAMINE SUCCINATE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A070156-001	DOXY-SLEEP-AID	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL			1987-07-02

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070156-001	DOXY-SLEEP-AID	25MG	TABLET / ORAL	1987-07-02	`f41ea6bd6efb…`

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 2 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Grocery Outlet	bc13c6c1-1706-4f8c-9789-448f7fe4628d	2026-03-18	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
NIGHTTIME SLEEP AID	DOXYLAMINE SUCCINATE	CVS Pharmacy	05050b61-2417-48f0-9478-c39d6a341026	2026-02-27	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
WALGREENS NIGHTTIME ALLERGY RELIEF	DOXYLAMINE SUCCINATE	WALGREENS CO.	a3c7df98-4611-4b61-9c03-5e687364bf74	2026-02-27	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	Walgreen Company	d812217b-b2f2-4716-92f4-c16bd0768e17	2026-02-11	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Unisom SleepTabs	DOXYLAMINE SUCCINATE	Chattem, Inc.	f591d52f-5610-4517-a96f-1ed63deb00bc	2026-01-14	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sambrosa Night	DOXYLAMINE SUCCINATE	Sambrosa Care, Inc.	acdc8740-6231-d1e8-e053-2995a90a3b8d	2026-01-07	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	8df4ac6d-f222-4218-9dcc-3df09c91d2ae	2026-01-06	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
SLEEP AID 25mg	DOXYLAMINE SUCCINATE	YYBA CORP	a436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a	2025-12-02	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
ZzzQuil ULTRA, Travel BASIX	DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc.	0f8c7219-7b40-27c6-e063-6294a90a27d9	2025-12-01	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Good sense sleep aid	DOXYLAMINE SUCCINATE	L. Perrigo Company	f0a0eb93-96e0-432b-9b82-f0e891483be0	2025-11-14	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Sleep Aid	DOXYLAMINE SUCCINATE	Kroger Company	76e1e49d-eb57-4590-8cf8-91f29dbd15c3	2025-08-22	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	CVS PHARMACY	0b08ca81-1d07-4a57-9cbd-72e3a6a37814	2025-08-19	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
Basic Care Sleep Aid	DOXYLAMINE SUCCINATE	Amazon.com Services LLC	e09cd229-638b-4065-8325-ed2c1ce2e99d	2025-08-19	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
sleep aid ultra	DOXYLAMINE SUCCINATE	Meijer, Inc.	792632af-01c1-4a9b-99f4-8eb84d0fc389	2025-06-16	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
sleep aid	DOXYLAMINE SUCCINATE	Publix Super Markets Inc	377ebf03-c1d5-4362-98b3-032206df9e8e	2025-05-23	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
good sense sleep aid ultra	DOXYLAMINE SUCCINATE	L. Perrigo Company	300826cf-6d0d-4efb-97aa-aa7dfff3add2	2025-04-02	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
up and up nighttime sleep aid	DOXYLAMINE SUCCINATE	Target Corporation	24a0144d-cbfc-4d2f-873d-86adfa0468ca	2025-04-02	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
CareOne Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	American Sales Company	f8bfc874-53be-41e8-b59c-d538825761a8	2025-04-01	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
berkley and jensen sleep aid	DOXYLAMINE SUCCINATE	BJWC	25f468a9-71d4-40f2-97bb-1c3ff5d4b728	2025-03-31	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE
topcare sleep aid	DOXYLAMINE SUCCINATE	Topco Associates LLC	c8b24ed8-34a1-4857-8fcb-6e3f9d407903	2025-03-26	Warnings	Name fallback generic name: DOXYLAMINE SUCCINATE

Reported adverse events (FAERS/openFDA)#

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