Application 207433

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDETABLET;ORAL75MGNoNo
005DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDETABLET;ORAL100MGNoNo
006DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDETABLET;ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207433-001DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2016-05-05
A207433-002DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2016-05-05
A207433-003DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2016-05-05
A207433-004DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE75MGTABLET / ORAL2016-05-05
A207433-005DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE100MGTABLET / ORAL2016-05-05
A207433-006DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDE150MGTABLET / ORAL2016-05-05

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORAL2016-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORAL2016-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-005DESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALAB2016-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-006DESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALAB2016-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-001DESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-002DESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-003DESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALAB2016-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-004DESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALAB2016-05-052680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207433-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207433-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207433-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207433-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207433-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207433-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207433-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207433-004AB15bbf6a4d5a75…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desipramine HydrochlorideDESIPRAMINE HYDROCHLORIDEChartwell RX, LLC6ab5e113-82ef-493d-a4e3-a2756608fa602025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207433
application number: ANDA207433
DESIPRAMINE HYDROCHLORIDEDESIPRAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ee14dd2c-c54b-4cd1-a3a0-f7ad5a5a0ed02025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207433
application number: ANDA207433
ndc (product): 23155-579
ndc (product): 23155-582
ndc (product): 23155-581
ndc (product): 23155-578
ndc (product): 23155-583
ndc (product): 23155-580

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-578DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-578DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-578Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-578Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-579DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-579DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-579Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-579Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-580DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-580DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-580Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-580Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-581DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-581DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-581Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-581Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-582DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-582DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-582Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-582Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-583DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-583DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-583Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-583Desipramine HydrochlorideDesipramine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
24724-067Desipramine HydrochlorideDesipramine HydrochlorideINDICUS PHARMA LLCANDACurrent
24724-068Desipramine HydrochlorideDesipramine HydrochlorideINDICUS PHARMA LLCANDACurrent
24724-069Desipramine HydrochlorideDesipramine HydrochlorideINDICUS PHARMA LLCANDACurrent
24724-070Desipramine HydrochlorideDesipramine HydrochlorideINDICUS PHARMA LLCANDACurrent
24724-071Desipramine HydrochlorideDesipramine HydrochlorideINDICUS PHARMA LLCANDACurrent
24724-072Desipramine HydrochlorideDesipramine HydrochlorideINDICUS PHARMA LLCANDACurrent
68788-7303Desipramine HydrochlorideDesipramine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-1021Desipramine HydrochlorideDesipramine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1021DESIPRAMINE HYDROCHLORIDEdesipramine hydrochlorideBryant Ranch PrepackANDACurrent