Application 204203

Type
ANDA
Sponsor
LUPIN 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 1.

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
A204203-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17
A204203-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17
A204203-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17
A204203-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17
A204203-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204203-001AB
A204203-002AB
A204203-003AB
A204203-004AB
A204203-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-05-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204203-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204203-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204203-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204203-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204203-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204203-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204203-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204203-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204203-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204203-005AB15bbf6a4d5a75…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINEMajor Pharmaceuticalsb02324b1-e7f0-4cbc-8778-5f7c4a5d194a2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204203
application number: ANDA204203
ndc (product): 0904-6802
ndc (product): 0904-6804
ndc (product): 0904-6801
ndc (product): 0904-6805
ndc (product): 0904-6803
QuetiapineQUETIAPINELupin Pharmaceuticals, Inc.7803a290-91c0-4e7f-90b5-d2ff33a46cee2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204203
application number: ANDA204203
ndc (product): 68180-613
ndc (product): 68180-615
ndc (product): 68180-614
ndc (product): 68180-612
ndc (product): 68180-616

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6801Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6802Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6803Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6804Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
0904-6805Quetiapine fumarateQuetiapine fumarateMajor PharmaceuticalsANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-612Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-613Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-614Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-615Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
68180-616Quetiapine fumarateQuetiapine fumarateLupin Pharmaceuticals, Inc.ANDACurrent
70518-0988Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1935Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2646Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2646Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2701Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2701Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent