Application 091388

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 25MG BASENoNo
002QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 50MG BASENoNo
003QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 100MG BASENoNo
004QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 150MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 200MG BASENoNo
006QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 300MG BASENoNo
007QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 400MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091388-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A091388-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A091388-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A091388-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27
A091388-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A091388-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A091388-007QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A091388-001AB
A091388-002AB
A091388-003AB
A091388-004AB
A091388-005AB
A091388-006AB
A091388-007AB

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 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091388-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091388-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091388-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091388-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091388-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091388-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091388-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091388-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091388-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091388-005AB103ed91905a0d…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATENorthStar Rx LLCe6e25ef9-2671-489e-8eca-58bedb4f59ab2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b90390d8-6ebc-48b3-8b4d-6a3ff7d19ef62026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack58541ffd-58c3-49aa-ad90-7e91a3c0b7d62026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackd3dcfb51-e67d-44dc-9186-4729f6414bf12026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackaa0d27fd-569a-4573-b45d-2de5f5a302942026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack897184b1-de3c-4d59-91be-3069325fd5b22026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.da5c118f-404c-4453-aa10-a8656b1d75012026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
ndc (product): 70518-3609
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.911bf26c-a89a-4ce1-8ff5-cfda03d0a4822026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
ndc (product): 70518-3581
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf0ad842c-a0c2-4855-a55b-353b5338980f2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.41dbd5a5-4ae2-4ac1-8135-0fdac5c170b52026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
ndc (product): 70518-3429
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions55018271-1f8f-4683-afee-8203c3bd9acc2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATERising Pharma Holdings, Inc.532c8ace-4cf5-4a08-bae7-2af8c41ffa3d2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
ndc (product): 16571-718
ndc (product): 16571-719
ndc (product): 16571-721
ndc (product): 16571-720
ndc (product): 16571-722
ndc (product): 16571-717
ndc (product): 16571-809
Quetiapine FumarateQUETIAPINE FUMARATECoupler LLC3eed13b8-7464-3720-e063-6294a90a12452025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack49ebd00b-e0a2-45c3-9cff-4b94d1a6b5ad2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEAurobindo Pharma Limited8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b62025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
ndc (product): 65862-493
ndc (product): 65862-489
ndc (product): 65862-491
ndc (product): 65862-494
ndc (product): 65862-490
ndc (product): 65862-495
ndc (product): 65862-492
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.951a098a-d905-4723-89e1-71bf1551dcb62025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxface6c19-3dd9-b188-e053-6294a90a62d02025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxfceb9f47-8da7-7138-e053-6294a90a55582025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.8acc0ed3-6e4f-4799-8252-5a163938fddc2025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.0fdbe32f-d04a-5666-e063-6294a90a8e362024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091388
application number: ANDA091388

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-717Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-717Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-717Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-718Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-718Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-718Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-719Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-719Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-719Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-720Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-720Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-720Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-721Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-721Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-721Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-722Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-722Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-722Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-809Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-809Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
16571-809Quetiapine FumarateQuetiapine FumarateRising Pharma Holdings, Inc.ANDACurrent
48433-324Quetiapine FumarateQuetiapine FumarateSafecor Health, LLCANDACurrent
57237-079Quetiapine FumarateQuetiapine FumarateCitron Pharma LLCANDACurrent
57237-080Quetiapine FumarateQuetiapine FumarateCitron Pharma LLCANDACurrent
57237-081Quetiapine FumarateQuetiapine FumarateCitron Pharma LLCANDACurrent
57237-082Quetiapine FumarateQuetiapine FumarateCitron Pharma LLCANDACurrent
57237-083Quetiapine FumarateQuetiapine FumarateCitron Pharma LLCANDACurrent
57237-084Quetiapine FumarateQuetiapine FumarateCitron Pharma LLCANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-489Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-490Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-491Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-492Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-493Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-494Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
65862-495Quetiapine FumarateQuetiapine FumarateAurobindo Pharma LimitedANDACurrent
70518-3429Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-3581Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent
70518-3609Quetiapine FumarateQuetiapine FumarateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9336ORIG2012-03-30