FDA.reportPublic FDA data

Application 206691

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERPHENAZINEPERPHENAZINETABLET;ORAL2MGNoNo
002PERPHENAZINEPERPHENAZINETABLET;ORAL4MGNoNo
003PERPHENAZINEPERPHENAZINETABLET;ORAL8MGNoNo
004PERPHENAZINEPERPHENAZINETABLET;ORAL16MGNoNo

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
A206691-001PERPHENAZINEPERPHENAZINE2MGTABLET / ORAL2017-04-14
A206691-002PERPHENAZINEPERPHENAZINE4MGTABLET / ORAL2017-04-14
A206691-003PERPHENAZINEPERPHENAZINE8MGTABLET / ORAL2017-04-14
A206691-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORAL2017-04-14

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 22:38:342026-08A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-1484e616aacf4f…
2026-09-14 22:38:342026-08A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-1484e616aacf4f…
2026-08-18 06:07:402026-07A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206691-001PERPHENAZINE2MGTABLET / ORAL2017-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206691-002PERPHENAZINE4MGTABLET / ORAL2017-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206691-003PERPHENAZINE8MGTABLET / ORAL2017-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206691-004PERPHENAZINE16MGTABLET / ORAL2017-04-145bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A206691-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206691-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206691-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206691-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206691-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206691-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206691-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206691-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206691-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206691-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206691-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206691-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206691-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206691-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206691-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206691-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206691-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206691-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206691-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206691-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206691-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206691-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206691-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206691-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206691-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206691-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206691-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206691-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206691-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206691-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206691-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206691-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206691-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206691-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206691-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206691-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206691-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206691-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206691-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206691-004AB1b00525d2431f…

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 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PERPHENAZINEPERPHENAZINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.935a7567-0395-4901-960c-79587fa14c8d2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PERPHENAZINE
generic name: PERPHENAZINE
perphenazinePERPHENAZINEZydus Pharmaceuticals (USA) Inc.c209f1f6-f440-4366-8140-1d24cf0c2ce62024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: perphenazine
generic name: PERPHENAZINE
perphenazinePERPHENAZINEZydus Lifesciences Limited003fe32c-a55d-4191-99fa-1013522b1b2e2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEWilshire Pharmaceuticals, Inc.5e455842-4892-4795-8c9b-4109a8f307832024-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEMacleods Pharmaceuticals Limited28f0cc81-538c-4a4b-be8d-509428fcbb9c2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINESandoz Incfc32500c-cc42-4f85-9cee-88f983fcbc162024-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackc644628a-76c2-40d9-b7d8-0077743713b92023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack0e87e78e-d39c-44fc-95a0-70cdb2a919412023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepacke2f9903c-cbac-4f14-b684-f12cc7e5aa852023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack18c20201-ad92-40ac-8f99-6048c2d32c682023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack9ad131c1-0620-4d3c-9734-bcffd98430e22023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack63e3a25b-a9e2-449d-8631-41f700f4cdeb2023-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack4882ec28-f516-4dc8-ab15-76cf455af7092023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepack59b1a63e-6cba-4102-a5e8-83dca540341d2023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PerphenazinePERPHENAZINEBryant Ranch Prepackb5f08bc9-79b5-4c6f-8fe4-ec2ef022ebe02023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Perphenazine
generic name: PERPHENAZINE
PERPHENAZINEPERPHENAZINEProficient Rx LP96322bdc-2183-413b-b7d4-c7192ba7666c2023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PERPHENAZINE
generic name: PERPHENAZINE

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5350PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5350PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5351PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5351PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5352PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5352PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5353PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
0378-5353PerphenazineperphenazineMylan Pharmaceuticals Inc.ANDACurrent
70518-1751PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-1751PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-1956PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-2821PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-2822PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent