FDA.reportPublic FDA data

Application 090441

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL50MGNoNo
002IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL25MGNoNo

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
A090441-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11
A090441-002IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11
A090441-003IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090441-002IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2010-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090441-003IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2010-03-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090441-001IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2010-03-111e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090441-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090441-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090441-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090441-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090441-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090441-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090441-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090441-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090441-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090441-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090441-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090441-003AB1ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELupin Pharmaceuticals, Inc.55311747-710c-43c4-821d-76323ff2520e2023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090441
application number: ANDA090441
ndc (product): 68180-313

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-313Imipramine HydrochlorideImipramine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent