Application 208947

Type
ANDA
Sponsor
NOVAST LABS

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
A208947-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A208947-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A208947-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A208947-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29
A208947-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208947-001AB
A208947-002AB
A208947-003AB
A208947-004AB
A208947-005AB

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 UTC2026-02A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-001QUETIAPINE FUMARATEEQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-002QUETIAPINE FUMARATEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-003QUETIAPINE FUMARATEEQ 200MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-004QUETIAPINE FUMARATEEQ 300MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-005QUETIAPINE FUMARATEEQ 400MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-295bbf6a4d5a75…

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 UTC2026-02A208947-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208947-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208947-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208947-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208947-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208947-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208947-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208947-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208947-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208947-005AB15bbf6a4d5a75…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEIngenus Pharmaceuticals, LLC8923c441-c9aa-4b30-89d7-dbaaa7f666562025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208947
application number: ANDA208947
ndc (product): 50742-636
ndc (product): 50742-639
ndc (product): 50742-637
ndc (product): 50742-635
ndc (product): 50742-638

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
34908-636Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
34908-637Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
34908-638Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
34908-639Quetiapine Fumaratequetiapine fumarateNovast Laboratories, Ltd.ANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-635Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-636Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-637Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-638Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
50742-639Quetiapine Fumaratequetiapine fumarateIngenus Pharmaceuticals, LLCANDACurrent
51407-073Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-073Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-073Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-074Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-074Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-074Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-075Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-075Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-075Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-076Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-076Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-076Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
51407-077Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply Inc.ANDACurrent
51407-077Quetiapine Fumaratequetiapine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-077Quetiapine Fumaratequetiapine fumarateGolden State Medical SupplyANDACurrent
70518-2280Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2282Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2309Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent
70518-2416Quetiapine Fumaratequetiapine fumarateREMEDYREPACK INC.ANDACurrent