Application 210653

Type
ANDA
Sponsor
TULEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo
002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL50MGNoNo
003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL75MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210653-001CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-04-03
A210653-002CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-04-03
A210653-003CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-04-03

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 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORAL2020-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORAL2020-04-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORAL2020-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-002CLOMIPRAMINE HYDROCHLORIDE50MGCAPSULE / ORALAB2020-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210653-003CLOMIPRAMINE HYDROCHLORIDE75MGCAPSULE / ORALAB2020-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210653-001CLOMIPRAMINE HYDROCHLORIDE25MGCAPSULE / ORALAB2020-04-031e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A210653-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210653-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210653-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210653-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210653-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210653-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210653-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210653-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210653-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210653-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210653-003AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210653-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210653-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210653-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210653-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210653-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210653-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210653-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210653-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210653-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210653-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210653-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210653-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210653-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210653-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210653-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210653-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210653-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210653-003AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210653-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210653-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210653-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210653-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210653-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210653-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210653-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210653-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210653-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210653-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210653-002AB1a72a2bbeb626…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDELeading Pharma, LLCfa0d4de8-c96e-429d-a65c-928afbf468632025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEMajor Pharmaceuticalseff91018-5a5e-4426-96ae-71ecd82273b72025-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEGolden State Medical Supply, Inc.fa2eb38c-b155-0d53-e053-6294a90a1d292025-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEMicro Labs Limited0bbee292-0fba-4606-9c8e-4723742682c02025-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.db752dbd-be41-4cdd-8a13-ed1ff9ef74612025-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.bf37fdc5-f579-48c9-baa3-8e516ac71a332025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDE CAPSULESLupin Pharmaceuticals, Inc.ebad19b5-e5dd-4f77-ab97-d20ce0f24cb92024-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
ANAFRANILCLOMIPRAMINE HYDROCHLORIDESpecGx LLC4074b555-7635-41a9-809d-fae3b36100592024-11-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDESpecGx LLCd7cee3fa-d05c-4702-8f75-f446627bdb492024-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAmerican Health Packaging1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e2024-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbe907f61-d918-45f1-89d7-ab61086c83a72024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDELifestar Pharma LLCa8dc192b-3334-4ca4-8862-3f320014dfb02023-11-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDEAurobindo Pharma Limited7d11010e-cf0f-4315-aced-7927a486a1ef2023-03-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbbf275df-2fe0-443c-99ca-2298721441dc2023-02-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Limited1b62b3c0-baf7-4c6b-815f-8707ce1f38c42023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDENorthstar Rx LLC.b1809cb2-c6a8-451a-b692-506456c4efc32022-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine HydrochlorideCLOMIPRAMINE HYDROCHLORIDEProficient Rx LPff9ed80e-d692-494f-9741-a9af30fa50002022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine Hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
Clomipramine hydrochlorideCLOMIPRAMINE HYDROCHLORIDEAjanta Pharma USA Inc.0bf3c4f3-cf70-490d-89d8-9fb84962489e2021-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clomipramine hydrochloride
generic name: CLOMIPRAMINE HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDECLOMIPRAMINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.73d14287-7aea-4971-b44d-6e1c9b575bb12021-10-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLOMIPRAMINE HYDROCHLORIDE
generic name: CLOMIPRAMINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-698clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-698clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-699clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-699clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-700clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-700clomiPRAMINE HydrochlorideCLOMIPRAMINE HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
52817-280Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-280Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-280Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-281Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-281Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-281Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-282Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-282Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent
52817-282Clomipramine Hydrochlorideclomipramine hydrochlorideTruPharma LLCANDACurrent