Application 040226

Type
ANDA
Sponsor
VINTAGE PHARMS

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 1.

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
A040226-001PERPHENAZINEPERPHENAZINE2MGTABLET / ORALAB1998-12-31
A040226-002PERPHENAZINEPERPHENAZINE4MGTABLET / ORALAB1998-12-31
A040226-003PERPHENAZINEPERPHENAZINE8MGTABLET / ORALAB1998-12-31
A040226-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORALAB1998-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040226-001AB
A040226-002AB
A040226-003AB
A040226-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040226-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040226-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040226-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-004AB1d06236e962d9…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerphenazinePERPHENAZINEAmerican Health Packaginga17c90f9-3d5d-4503-ba2c-754b45decbf82025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 68084-602
ndc (product): 68084-607
PerphenazinePERPHENAZINEMajor Pharmaceuticals0dc77ea9-32ee-4b6d-b69d-8c712bcf5fe42025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 0904-6600
ndc (product): 0904-6601
ndc (product): 0904-6599
PerphenazinePERPHENAZINEEndo USA, Inc.5fbfe9da-26e8-4705-98f3-42acd3d7b4392024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 0603-5061
ndc (product): 0603-5062
ndc (product): 0603-5060
ndc (product): 0603-5063
PerphenazinePERPHENAZINEBryant Ranch Prepackc644628a-76c2-40d9-b7d8-0077743713b92023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 63629-2249
PerphenazinePERPHENAZINEBryant Ranch Prepack0e87e78e-d39c-44fc-95a0-70cdb2a919412023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 63629-2252
PerphenazinePERPHENAZINEBryant Ranch Prepacke2f9903c-cbac-4f14-b684-f12cc7e5aa852023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 63629-2250
PerphenazinePERPHENAZINEBryant Ranch Prepack18c20201-ad92-40ac-8f99-6048c2d32c682023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack9ad131c1-0620-4d3c-9734-bcffd98430e22023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack63e3a25b-a9e2-449d-8631-41f700f4cdeb2023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack4882ec28-f516-4dc8-ab15-76cf455af7092023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 63629-2248
PerphenazinePERPHENAZINEBryant Ranch Prepack59b1a63e-6cba-4102-a5e8-83dca540341d2023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 63629-2251
PerphenazinePERPHENAZINEBryant Ranch Prepackb5f08bc9-79b5-4c6f-8fe4-ec2ef022ebe02023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
ndc (product): 63629-2253

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 80 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-5060PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5060PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5060PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5060PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5061PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5061PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5061PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5061PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5062PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5062PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5062PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5062PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5063PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5063PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0603-5063PerphenazineperphenazinePar PharmaceuticalANDACurrent
0603-5063PerphenazineperphenazinePar Pharmaceutical, Inc.ANDACurrent
0904-6599PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6599PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6599PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6599PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6599PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6600PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6600PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6600PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6600PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6600PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6601PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6601PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6601PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6601PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
0904-6601PerphenazineperphenazineMajor PharmaceuticalsANDACurrent
52959-940PerphenazineperphenazineH.J. Harkins Company, Inc.ANDACurrent
53808-0395PerphenazineperphenazineState of Florida DOH Central PharmacyANDACurrent
53808-0761PerphenazineperphenazineState of Florida DOH Central PharmacyANDACurrent
53808-0885PerphenazineperphenazineState of Florida DOH Central PharmacyANDACurrent
53808-0938PerphenazineperphenazineState of Florida DOH Central PharmacyANDACurrent
53808-1023PerphenazineperphenazineState of Florida DOH Central PharmacyANDACurrent
63629-2248PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2248PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2248PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2249PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2249PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2249PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2249PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2250PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2250PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2250PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2250PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2251PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2251PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2251PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2252PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2252PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2252PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2253PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2253PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-2253PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-7252PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-7252PerphenazineperphenazineBryant Ranch PrepackANDACurrent
63629-7252PerphenazineperphenazineBryant Ranch PrepackANDACurrent
68084-602PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-602PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-602PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-602PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-607PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-607PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-607PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-607PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-830PerphenazineperphenazineAmerican Health PackagingANDACurrent
68084-842PerphenazineperphenazineAmerican Health PackagingANDACurrent
70518-0458PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-0458PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-0458PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-1717PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-1717PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-2639PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-2639PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-2639PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-2639PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent
70518-3106PerphenazineperphenazineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29897ORIG2004-06-14
17754ORIG2004-06-14
42597ORIG2003-07-30