Application 207655

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
A207655-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A207655-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A207655-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A207655-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A207655-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A207655-001AB
A207655-002AB
A207655-003AB
A207655-004AB
A207655-005AB

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 22:38:342026-08A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-09-14 22:38:342026-08A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2984e616aacf4f…
2026-08-18 06:07:402026-07A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-08-18 06:07:402026-07A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207655-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207655-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207655-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207655-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207655-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207655-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207655-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207655-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207655-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207655-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207655-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207655-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207655-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207655-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207655-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207655-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207655-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207655-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207655-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207655-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207655-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207655-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207655-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207655-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207655-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207655-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207655-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207655-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207655-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207655-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207655-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207655-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207655-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207655-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207655-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207655-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207655-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207655-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207655-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207655-005AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207655-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207655-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207655-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207655-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207655-005AB18072bd15b7f6…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINEAurobindo Pharma Limited6562eb60-0d70-4909-bd07-88d5c92415162025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207655
application number: ANDA207655
ndc (product): 65862-874
ndc (product): 65862-877
ndc (product): 65862-873
ndc (product): 65862-875
ndc (product): 65862-876

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 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3595Quetiapine FumarateQuetiapineA-S Medication SolutionsANDACurrent
50090-5451Quetiapine FumarateQuetiapineA-S Medication SolutionsANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-873Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-874Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-875Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-876Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent
65862-877Quetiapine FumarateQuetiapineAurobindo Pharma LimitedANDACurrent