Application 040185

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATETABLET;ORALEQ 10MG BASENoNo
002PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATETABLET;ORALEQ 5MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040185-001PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28
A040185-002PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040185-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040185-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040185-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040185-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040185-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040185-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040185-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040185-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040185-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040185-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040185-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040185-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040185-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040185-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040185-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040185-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040185-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040185-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040185-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040185-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040185-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040185-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040185-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040185-002AB1ea99ee380514…
2022-09-29 23:25 UTC2022-09A040185-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A040185-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040185-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040185-002AB1cb3db0bc1861…

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEMajor Pharmaceuticalsd6fc83ad-9cce-4e60-854c-3825313ee60c2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Prochlorperazine Maleate
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATESportpharm LLC3d28dab2-0264-482e-b99d-f56a9314b8a52026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEREMEDYREPACK INC.5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEANI Pharmaceuticals, Inc.50ce4381-94ef-49ff-8794-cfde0ee803b42026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Prochlorperazine Maleate
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPD-Rx Pharmaceuticals, Inc.fc77a504-4642-47c1-b2e3-c5db11e5816d2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleatePROCHLORPERAZINE MALEATEAmneal Pharmaceuticals NY LLCa2a48790-0634-4b46-b362-98b7c252836f2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: prochlorperazine maleate
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBryant Ranch Prepack7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEA-S Medication Solutions8b58b63c-0a75-406b-bb29-acf0a40353bd2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEGLENMARK PHARMACEUTICALS INC., USA9c806152-70d0-43eb-b183-b51b12b82b312026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATENorthwind Health Company, LLC115a4125-07df-9f9b-e063-6394a90a3e492026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Prochlorperazine Maleate
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENorthwind Health Company, LLCc524a28e-1e08-4aa6-a9f0-0a3280a3c2132026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENorthwind Health Company, LLCf2f12ccc-6e51-0a67-e053-2995a90a22bc2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedpharm Drug44f278eb-3588-af83-e063-6394a90a73cf2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEQPharma, Inc.dc692e77-5240-4aa6-8fe9-9ffcbb2672612025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPD-Rx Pharmaceuticals, Inc.3b022837-0fcc-d38a-e063-6394a90a0f7f2025-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEJubilant Cadista Pharmaceuticals Inc.b05bc20e-cd19-ab40-1ad0-84a115d6d69e2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATECardinal Health 107, LLC45f56f93-50a7-4cd3-bce2-f97a805566512025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEA-S Medication Solutionsf387b07a-2d99-4fd5-bcd1-8f04e69b8a392025-12-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedpharm Drug3dd03606-1f58-43ac-e063-6294a90a44392025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCHLORPERAZINE MALEATE
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEAjanta Pharma USA Inc.9ab78746-b302-4836-95f3-343799929c0e2025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Prochlorperazine Maleate
generic name: PROCHLORPERAZINE MALEATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5105Prochlorperazine Maleateprochlorperazine maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-5105Prochlorperazine Maleateprochlorperazine maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-5110Prochlorperazine Maleateprochlorperazine maleateMylan Pharmaceuticals Inc.ANDACurrent
0378-5110Prochlorperazine Maleateprochlorperazine maleateMylan Pharmaceuticals Inc.ANDACurrent
0615-2519Prochlorperazine Maleateprochlorperazine maleateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2520Prochlorperazine Maleateprochlorperazine maleateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
35356-672Prochlorperazine Maleateprochlorperazine maleateLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-160Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-353Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-353Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-353Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-607Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0110Prochlorperazine Maleateprochlorperazine maleateA-S Medication SolutionsANDACurrent
50090-0110Prochlorperazine Maleateprochlorperazine maleateA-S Medication SolutionsANDACurrent
50090-0111Prochlorperazine Maleateprochlorperazine maleateA-S Medication SolutionsANDACurrent
50090-1854Prochlorperazine Maleateprochlorperazine maleateA-S Medication SolutionsANDACurrent
50090-1854Prochlorperazine Maleateprochlorperazine maleateA-S Medication SolutionsANDACurrent
51079-541Prochlorperazine Maleateprochlorperazine maleateMylan Institutional Inc.ANDACurrent
51079-541Prochlorperazine Maleateprochlorperazine maleateMylan Institutional Inc.ANDACurrent
51079-542Prochlorperazine Maleateprochlorperazine maleateMylan Institutional Inc.ANDACurrent
51079-542Prochlorperazine Maleateprochlorperazine maleateMylan Institutional Inc.ANDACurrent
55154-5094Prochlorperazine Maleateprochlorperazine maleateCardinal HealthANDACurrent
55154-5094Prochlorperazine Maleateprochlorperazine maleateCardinal HealthANDACurrent
55289-224Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, InANDACurrent
55289-224Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-224Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-224Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-568Prochlorperazine Maleateprochlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-653Prochlorperazine MaleateProchlorperazine MaleateDirect_RxANDACurrent
67296-0027Prochlorperazine Maleateprochlorperazine maleateRedPharm Drug, Inc.ANDACurrent
67296-1405Prochlorperazine MaleateProchlorperazine MaleateRedPharm Drug, Inc.ANDACurrent
67296-1405Prochlorperazine MaleateProchlorperazine MaleateRedPharm Drug, Inc.ANDACurrent
70518-0768Prochlorperazine Maleateprochlorperazine maleateREMEDYREPACK INC.ANDACurrent
70518-0768Prochlorperazine Maleateprochlorperazine maleateREMEDYREPACK INC.ANDACurrent
71335-0543Prochlorperazine Maleateprochlorperazine maleateBryant Ranch PrepackANDACurrent
71335-0543Prochlorperazine Maleateprochlorperazine maleateBryant Ranch PrepackANDACurrent