Application 201190

Type
ANDA
Sponsor
SUN PHARM

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 200MG BASENoNo
005QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;ORALEQ 300MG BASENoNo
006QUETIAPINE FUMARATEQUETIAPINE FUMARATETABLET;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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201190-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2012-03-27
A201190-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A201190-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A201190-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2012-03-27
A201190-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A201190-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201190-002AB
A201190-003AB
A201190-005AB

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 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201190-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A201190-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2012-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORAL2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORAL2012-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORAL2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 247 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A201190-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A201190-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A201190-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A201190-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201190-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201190-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201190-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201190-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201190-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201190-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201190-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201190-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201190-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201190-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201190-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201190-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201190-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201190-006AB103ed91905a0d…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepackc52a9bff-8a03-44f5-9128-799c7dca04672026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201190
application number: ANDA201190
ndc (product): 71335-2157
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack3eb39b4e-4c79-43b9-a30e-b4221c0e2bd22026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201190
application number: ANDA201190
ndc (product): 71335-2176
Quetiapine fumarateQUETIAPINE FUMARATESun Pharmaceutical Industries, Inc.ffe52b98-9872-48c1-90fd-8fcd37c3432f2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201190
application number: ANDA201190
ndc (product): 47335-903
ndc (product): 47335-906
ndc (product): 47335-904
ndc (product): 47335-905
ndc (product): 47335-902
ndc (product): 47335-907
Quetiapine fumarateQUETIAPINE FUMARATECoupler LLC258eac65-69ed-404f-e063-6394a90a19ef2025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201190
application number: ANDA201190
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack9a024071-e620-48e8-9f22-d4cda5dc5ab12025-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201190
application number: ANDA201190
ndc (product): 71335-0772

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-902Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-903Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-904Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-905Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-906Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-907Quetiapine fumarateQuetiapine fumarateSun Pharmaceutical Industries, Inc.ANDACurrent
55700-084Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-085Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-085Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA QuaANDACurrent
55700-156Quetiapine fumarateQuetiapine fumarateLake Erie Medical DBA Quality Care Products LLCANDACurrent
68071-2728Quetiapine fumarateQuetiapine fumarateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7950Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7950Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7960Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7960Quetiapine fumarateQuetiapine fumaratePreferred Pharmaceuticals Inc.ANDACurrent
70518-0556Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0556Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0594Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0594Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0594Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0767Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0767Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-0767Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1126Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1126Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-1833Quetiapine fumarateQuetiapine fumarateREMEDYREPACK INC.ANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-0772Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-2157Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-2157Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent
71335-2176Quetiapine fumarateQuetiapine fumarateBryant Ranch PrepackANDACurrent