Application 040209

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo
002TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
003TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
004TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040209-001TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-07
A040209-002TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-07
A040209-003TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-07
A040209-004TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A040209-001AB
A040209-002AB
A040209-003AB
A040209-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-0784e616aacf4f…
2026-08-18 06:07:402026-07A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040209-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1997-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040209-002TRIFLUOPERAZINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1997-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040209-003TRIFLUOPERAZINE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1997-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040209-004TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRS1997-07-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-02-18 07:12 UTC2024-02A040209-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040209-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040209-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040209-004AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040209-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040209-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040209-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040209-004AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040209-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040209-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040209-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040209-004AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040209-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040209-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040209-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040209-004AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040209-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040209-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040209-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040209-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040209-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040209-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040209-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040209-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040209-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A040209-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A040209-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A040209-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040209-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A040209-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A040209-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A040209-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040209-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040209-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040209-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040209-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040209-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040209-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040209-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040209-004AB1f41ea6bd6efb…

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
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDESafecor Health LLC8501543b-0c74-4087-9946-e7198400814a2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040209
application number: ANDA040209
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEREMEDYREPACK INC.339ceb53-3b1c-459f-84eb-77bd4315c9982026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040209
application number: ANDA040209
ndc (product): 70518-2095
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEREMEDYREPACK INC.6a05900b-ca43-483a-a460-8ac378653f122026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040209
application number: ANDA040209
ndc (product): 70518-2106
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEMylan Institutional Inc.f742a579-411a-4140-91c4-edc735d638fa2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040209
application number: ANDA040209
ndc (product): 51079-573
ndc (product): 51079-575
ndc (product): 51079-572
ndc (product): 51079-574
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEMylan Pharmaceuticals Inc.c2575a86-19e5-44df-8603-ff066bb9c9c52025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040209
application number: ANDA040209
ndc (product): 0378-2401
ndc (product): 0378-2410
ndc (product): 0378-2402
ndc (product): 0378-2405

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 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2401Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2401Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2401Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2401Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2402Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2402Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2402Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2402Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2405Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2405Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2405Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2405Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2410Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2410Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2410Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2410Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
35356-823Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
51079-572Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-572Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-572Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-573Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-573Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-573Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-574Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-574Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-574Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-575Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-575Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-575Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideMylan Institutional Inc.ANDACurrent
53808-0629Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0819Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideState of Florida DOH Central PharmacyANDACurrent
70518-1960Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1960Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1960Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1960Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2095Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2095Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2095Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2095Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2095Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2106Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2106Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2106Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2106Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2106Trifluoperazine Hydrochloridetrifluoperazine hydrochlorideREMEDYREPACK INC.ANDACurrent