Application 201504

Type
ANDA
Sponsor
ALKEM LABS 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 43.

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
A201504-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12
A201504-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12
A201504-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12
A201504-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12
A201504-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12
A201504-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12
A201504-007QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201504-001AB
A201504-002AB
A201504-003AB
A201504-004AB
A201504-005AB
A201504-006AB
A201504-007AB

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 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-09-14 22:38:342026-08A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-1284e616aacf4f…
2026-08-18 06:07:402026-07A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-006QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-007QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2013-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-004QUETIAPINE FUMARATEEQ 150MG BASETABLET / ORALAB2013-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-005QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2013-02-12fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A201504-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A201504-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A201504-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201504-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201504-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201504-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201504-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201504-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201504-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201504-005AB1fd3edfee7708…

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP392dd5cf-4777-4985-b62b-7370134dee262024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutionsccacb909-8ee5-4223-bfee-9cfeae470ecf2023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
ndc (product): 50090-5884
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP85f973e0-93e6-4856-9266-62136acb25322023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions95156201-ed16-4806-98a7-d42acc9021262023-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
ndc (product): 50090-5473
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LPc1f2ccba-62f3-44e7-b06f-dea61eac9e932023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP03517f29-f270-4350-a57a-fbe1967b00962019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201504
application number: ANDA201504

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 3 · 230 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6638Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6638Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6638Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6638Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6639Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6639Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6639Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6639Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6640Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6640Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6640Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6640Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6641Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6641Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6641Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6641Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6642Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6642Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6642Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6642Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6643Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6643Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6643Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
0904-6643Quetiapine FumarateQuetiapine FumarateMajor PharmaceuticalsANDACurrent
50090-3333Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3333Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3333Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3333Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3333Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3342Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3342Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3342Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3342Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-3351Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-5473Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50090-5884Quetiapine FumarateQuetiapine FumarateA-S Medication SolutionsANDACurrent
50268-630Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-630Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-630Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-631Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-631Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-631Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-632Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-632Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-632Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-633Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-633Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-633Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-634Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-634Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-634Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-635Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-635Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
50268-635Quetiapine FumarateQuetiapine FumarateAvPAKANDACurrent
55154-3359Quetiapine FumarateQuetiapine FumarateCardinal Health 107, LLCANDACurrent
55154-3359Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-3359Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7881Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7881Quetiapine FumarateQuetiapine FumarateCardinal Health 107, LLCANDACurrent
55154-7881Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7881Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7881Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7881Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7894Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7894Quetiapine FumarateQuetiapine FumarateCardinal Health 107, LLCANDACurrent
55154-7894Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7894Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7894Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-7894Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-8092Quetiapine FumarateQuetiapine FumarateCardinal Health 107, LLCANDACurrent
55154-8092Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-8092Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55154-8092Quetiapine FumarateQuetiapine FumarateCardinal HealthANDACurrent
55700-903Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
55700-903Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
55700-903Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
55700-903Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
55700-941Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
55700-941Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent
55700-941Quetiapine FumarateQuetiapine FumarateQuality Care Products, LLCANDACurrent