Application 077745

Type
ANDA
Sponsor
TEVA PHARMS

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
A077745-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A077745-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A077745-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A077745-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27
A077745-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A077745-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A077745-007QUETIAPINE 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
A077745-001AB
A077745-002AB
A077745-003AB
A077745-004AB
A077745-005AB
A077745-006AB
A077745-007AB

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 UTC2026-02A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-005QUETIAPINE 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 UTC2026-02A077745-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077745-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077745-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077745-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077745-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077745-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077745-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077745-005AB103ed91905a0d…

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINETeva Pharmaceuticals USA, Inc.c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
ndc (product): 0093-8166
ndc (product): 0093-8165
ndc (product): 0093-8163
ndc (product): 0093-8162
ndc (product): 0093-2063
ndc (product): 0093-8164
QuetiapineQUETIAPINEAphena Pharma Solutions - Tennessee, LLCfdece055-aeb5-43d6-b730-54dd74bde3042023-04-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
QuetiapineQUETIAPINEProficient Rx LPdd6b6088-943e-413b-9886-88dd9c622be42022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
ndc (product): 71205-026
QuetiapineQUETIAPINEProficient Rx LP6258bbaf-4ac0-4621-b95e-e6b032aa05182020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077745
application number: ANDA077745
ndc (product): 71205-402

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2063QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8162QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8163QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8164QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8165QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8166QuetiapineQuetiapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7724Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7725Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7726Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7727Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7728Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7846Quetiapine FumarateQuetiapine FumarateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-695QuetiapineQuetiapineAvKAREANDACurrent
42291-696QuetiapineQuetiapineAvKAREANDACurrent
42291-697QuetiapineQuetiapineAvKAREANDACurrent
42291-698QuetiapineQuetiapineAvKAREANDACurrent
42291-699QuetiapineQuetiapineAvKAREANDACurrent
42291-700QuetiapineQuetiapineAvKAREANDACurrent
43353-011Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-955Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-957Quetiapine FumarateQuetiapine FumarateAphena Pharma Solutions - Tennessee, LLCANDACurrent
64725-8166Quetiapine FumarateQuetiapine FumarateTYA PharmaceuticalsANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-026QuetiapineQuetiapineProficient Rx LPANDACurrent
71205-402QuetiapineQuetiapineProficient Rx LPANDACurrent
71610-538QuetiapineQuetiapineAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31287ORIG2012-03-29