Application 213590

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL100MGNoNo
005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL200MGNoNo

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

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
A213590-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-31
A213590-002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-31
A213590-003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-31
A213590-004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-31
A213590-005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213590-001AB
A213590-002AB
A213590-003AB
A213590-004AB
A213590-005AB

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 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-3184e616aacf4f…
2026-09-14 22:38:342026-08A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-3184e616aacf4f…
2026-09-14 22:38:342026-08A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-3184e616aacf4f…
2026-09-14 22:38:342026-08A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-3184e616aacf4f…
2026-09-14 22:38:342026-08A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-001CHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2020-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-002CHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2020-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-003CHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2020-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-004CHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2020-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-005CHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2020-08-3103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213590-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213590-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213590-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A213590-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A213590-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A213590-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213590-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213590-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213590-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213590-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213590-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213590-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213590-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213590-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213590-005AB103ed91905a0d…

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 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEEugia US LLC07e6144a-b460-4887-b8e2-dd371c14a55c2025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CHLORPROMAZINE HYDROCHLORIDE
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEZydus Lifesciences Limitedd37a4c21-b503-4791-a4d0-2ccc8891d88e2025-11-04Name fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEHenry Schein, Inc.310d161e-c4db-49e8-8665-d1a6d4e113202025-10-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CHLORPROMAZINE HYDROCHLORIDE
generic name: CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEAdvagen Pharma Ltd02c56c39-99bd-44a4-8d9d-9d867c3239682025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEPiramal Critical Care Inc.251ee159-bcf1-01f6-e063-6394a90aa4142025-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDELannett Company, Inc.1049538a-c012-41bf-932e-3c85f57f95772025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDESandoz, Inc.9398a0b4-e08b-4eb7-9f31-97d4f384427a2025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDECoupler LLC35a743a1-5354-2c50-e063-6394a90a15f92025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEDevatis, Inc.b73b9044-7132-41b7-83d4-2d135ea831f12025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.6564346c-661c-41cf-9cef-db6aa15710cd2025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CHLORPROMAZINE HYDROCHLORIDE
generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEFresenius Kabi USA, LLC5831e15a-3efa-48bb-9d49-8451f78d98682025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CHLORPROMAZINE HYDROCHLORIDE
generic name: CHLORPROMAZINE HYDROCHLORIDE
ChlorproMAZINE HydrochlorideCHLORPROMAZINE HYDROCHLORIDEZameer Pharmaceuticals LLCda3c2935-817d-4331-83c3-ed68ba5d35fd2024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ChlorproMAZINE Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEGland Pharma Limited867d5c7f-52d4-4794-b1d4-6747f3262fba2024-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.fc2bd95d-a7bc-4ab5-bffa-f5059cb8eb632024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEZydus Lifesciences Limited0ea5e0c6-0062-4be3-96f2-62397da3e77d2024-06-04Name fallback
brand name: Chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.c0f1fcfd-8863-4032-bf80-185df60a4ba02024-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAa6065ac5-a111-449b-b51b-8bc2907d1ddb2023-10-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.7cd6dc0d-e98d-40ae-80d4-c15f63056abf2023-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDENovadoz Pharmaceuticals LLC315ce03f-d9f8-4f3a-9e83-922747430c232022-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Chlorpromazine Hydrochloride
generic name: CHLORPROMAZINE HYDROCHLORIDE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-590ChlorpromazineChlorpromazine HydrochlorideMayne Pharma Inc.ANDACurrent
51862-592ChlorpromazineChlorpromazine HydrochlorideMayne Pharma Inc.ANDACurrent
51862-594ChlorpromazineChlorpromazine HydrochlorideMayne Pharma Inc.ANDACurrent
51862-596ChlorpromazineChlorpromazine HydrochlorideMayne Pharma Inc.ANDACurrent
51862-598ChlorpromazineChlorpromazine HydrochlorideMayne Pharma Inc.ANDACurrent