Application 090482

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 150MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 200MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 300MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090482-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09
A090482-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09
A090482-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09
A090482-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09
A090482-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0984e616aacf4f…
2026-09-14 22:38:342026-08A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0984e616aacf4f…
2026-09-14 22:38:342026-08A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0984e616aacf4f…
2026-09-14 22:38:342026-08A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0984e616aacf4f…
2026-09-14 22:38:342026-08A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0984e616aacf4f…
2026-08-18 06:07:402026-07A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090482-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090482-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090482-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090482-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090482-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090482-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090482-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090482-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090482-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090482-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090482-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090482-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090482-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090482-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090482-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090482-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090482-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090482-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090482-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090482-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090482-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090482-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090482-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090482-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090482-005AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090482-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090482-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090482-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090482-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090482-005AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090482-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090482-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090482-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090482-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090482-005AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090482-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090482-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090482-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090482-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090482-005AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090482-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090482-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090482-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090482-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090482-005AB15aa47cf7b7d7…

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 4 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATERising Pharma Holdings, Inc.532c8ace-4cf5-4a08-bae7-2af8c41ffa3d2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATECoupler LLC3eed13b8-7464-3720-e063-6294a90a12452025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINEAurobindo Pharma Limited6562eb60-0d70-4909-bd07-88d5c92415162025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack49ebd00b-e0a2-45c3-9cff-4b94d1a6b5ad2025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAurobindo Pharma Limited8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b62025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf75a4d38-ea0e-4780-abf2-67672894a11b2025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxe4ce9d50-9786-2233-e053-2a95a90a276f2025-06-16Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEST. MARY'S MEDICAL PARK PHARMACY3624c430-2a17-a83a-e063-6394a90add932025-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack6efc2886-7dcc-4dac-a212-76078a7efaa72025-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATECoupler LLC258eac65-69ed-404f-e063-6394a90a19ef2025-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack45947f72-d870-4f6e-9e5f-38d6b324d5fe2025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack35b2069e-209a-41ac-84e6-377d4f19be872025-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack9a024071-e620-48e8-9f22-d4cda5dc5ab12025-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.951a098a-d905-4723-89e1-71bf1551dcb62025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEGolden State Medical Supply, Inc.6fc9c8e2-6f34-aa43-e053-2a91aa0ac3772025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack1618989e-2e6b-49ff-81b5-cf80d1dcfab42025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATENCS HealthCare of KY, LLC dba Vangard Labsd73655d3-4b3f-40b4-92cb-053ad4f21a922025-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEUnichem Pharmaceuticals (USA), Inc.bdc9354b-172e-4bb3-895a-6c7cfef0ef142025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.69275af7-1469-4405-a98e-e8b0f8d42dd92025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEHikma Pharmaceuticals USA Inc.271e9fb7-3c70-43fc-8279-5adf189f3c222025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quetiapine Fumarate
generic name: QUETIAPINE FUMARATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31475ORIG2017-06-21
48372ORIG2017-05-15