FDA.reportPublic FDA data

Application 088603

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATETABLET;ORAL25MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088603-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088603-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1984-08-07cb3db0bc1861…

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 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDOXYLAMINE SUCCINATEGrocery Outletbc13c6c1-1706-4f8c-9789-448f7fe4628d2026-03-18WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
NIGHTTIME SLEEP AIDDOXYLAMINE SUCCINATECVS Pharmacy05050b61-2417-48f0-9478-c39d6a3410262026-02-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
WALGREENS NIGHTTIME ALLERGY RELIEFDOXYLAMINE SUCCINATEWALGREENS CO.a3c7df98-4611-4b61-9c03-5e687364bf742026-02-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEWalgreen Companyd812217b-b2f2-4716-92f4-c16bd0768e172026-02-11WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.f591d52f-5610-4517-a96f-1ed63deb00bc2026-01-14WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sambrosa NightDOXYLAMINE SUCCINATESambrosa Care, Inc.acdc8740-6231-d1e8-e053-2995a90a3b8d2026-01-07WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEL.N.K. International, Inc.8df4ac6d-f222-4218-9dcc-3df09c91d2ae2026-01-06WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
SLEEP AID 25mgDOXYLAMINE SUCCINATEYYBA CORPa436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a2025-12-02WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
ZzzQuil ULTRA, Travel BASIXDOXYLAMINE SUCCINATELil' Drug Store Products, Inc.0f8c7219-7b40-27c6-e063-6294a90a27d92025-12-01WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Good sense sleep aidDOXYLAMINE SUCCINATEL. Perrigo Companyf0a0eb93-96e0-432b-9b82-f0e891483be02025-11-14WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Vicks ZzzQuil UltraDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyc29f6f9a-7b55-30c3-e053-2995a90a9de72025-10-02WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep-AidDOXYLAMINE SUCCINATEKroger Company8b85812e-33a3-4534-bfba-ee4502d11d342025-09-23WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEKroger Company76e1e49d-eb57-4590-8cf8-91f29dbd15c32025-08-22WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATECVS PHARMACY0b08ca81-1d07-4a57-9cbd-72e3a6a378142025-08-19WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATECOSTCO WHOLESALE CORPORATION74a728e1-9ca1-4219-9427-b503ab0480b42025-08-19WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Basic Care Sleep AidDOXYLAMINE SUCCINATEAmazon.com Services LLCe09cd229-638b-4065-8325-ed2c1ce2e99d2025-08-19WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
sleep aid ultraDOXYLAMINE SUCCINATEMeijer, Inc.792632af-01c1-4a9b-99f4-8eb84d0fc3892025-06-16WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
sleep aidDOXYLAMINE SUCCINATEPublix Super Markets Inc377ebf03-c1d5-4362-98b3-032206df9e8e2025-05-23WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
good sense sleep aid ultraDOXYLAMINE SUCCINATEL. Perrigo Company300826cf-6d0d-4efb-97aa-aa7dfff3add22025-04-02WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
up and up nighttime sleep aidDOXYLAMINE SUCCINATETarget Corporation24a0144d-cbfc-4d2f-873d-86adfa0468ca2025-04-02WarningsName fallback
generic name: DOXYLAMINE SUCCINATE