Application 040903

Type
ANDA
Sponsor
LEADING PHARMA LLC

Application Products#

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

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
A040903-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24
A040903-002IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24
A040903-003IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040903-001AB
A040903-002AB
A040903-003AB

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 06:07:402026-07A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-002IMIPRAMINE HYDROCHLORIDE25MGTABLET / ORALAB2012-10-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-003IMIPRAMINE HYDROCHLORIDE50MGTABLET / ORALABRS2012-10-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB2012-10-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040903-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040903-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040903-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040903-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040903-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040903-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040903-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040903-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040903-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040903-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040903-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040903-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040903-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040903-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040903-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040903-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040903-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040903-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040903-001AB11e350fbaab3a…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELeading Pharma, LLC490263ce-b4d2-428a-87da-fcd07f85499a2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
ndc (product): 69315-135
ndc (product): 69315-134
ndc (product): 69315-133
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEA-S Medication Solutionsd9dbcebe-9aba-4a93-a7b7-48d29e07d3c42026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
ndc (product): 50090-3148
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7091ff32-55b9-48fd-a86d-c502af57473f2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.649837df-147f-436c-9553-32ffecf4c6f12026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbcd3b62a-88d4-49eb-b0aa-71e28cf409192026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.db007ac0-020e-4962-8903-7497ab96a74e2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
ndc (product): 70518-1588
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDECoupler LLC48e8b819-a9a0-aa5a-e063-6394a90ad9c22026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepack20af582f-08ba-4281-a2df-0bcf68c585942025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine hydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf887062a-7c82-664f-e053-6294a90a27732024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP3f90b8dd-7234-4428-b896-943d052dd05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040903
application number: ANDA040903

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-345Imipramine HydrochlorideImipramine HydrochlorideAvKARE, Inc.ANDACurrent
42291-345Imipramine HydrochlorideImipramine HydrochlorideAvKAREANDACurrent
42291-346Imipramine HydrochlorideImipramine HydrochlorideAvKARE, Inc.ANDACurrent
42291-346Imipramine HydrochlorideImipramine HydrochlorideAvKAREANDACurrent
42291-347Imipramine HydrochlorideImipramine HydrochlorideAvKARE, Inc.ANDACurrent
42291-347Imipramine HydrochlorideImipramine HydrochlorideAvKAREANDACurrent
50090-3148Imipramine HydrochlorideImipramine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3148Imipramine HydrochlorideImipramine HydrochlorideA-S Medication SolutionsANDACurrent
55700-709Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-709Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-709Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-709Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-709Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-709Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLANDACurrent
55700-710Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-710Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-710Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLCANDACurrent
55700-710Imipramine HydrochlorideImipramine HydrochlorideQuality Care Products, LLANDACurrent
64125-133Imipramine HydrochlorideImipramine HydrochlorideExcellium Pharmaceutical, IncANDACurrent
64125-134Imipramine HydrochlorideImipramine HydrochlorideExcellium Pharmaceutical, IncANDACurrent
64125-135Imipramine HydrochlorideImipramine HydrochlorideExcellium Pharmaceutical, IncANDACurrent
69315-133Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-133Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-133Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-133Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-134Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-134Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-134Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-134Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-135Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-135Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-135Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
69315-135Imipramine HydrochlorideImipramine HydrochlorideLeading Pharma, LLCANDACurrent
70518-0006Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0006Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0127Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1588Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1588Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1588Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1588Imipramine HydrochlorideImipramine HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38902ORIG2013-10-04