Application 088292

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL10MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088292-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088292-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213f01610625f2…
2019-09-15 20:21 UTC2019-09A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A088292-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088292-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088292-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088292-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088292-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088292-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088292-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088292-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088292-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088292-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088292-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088292-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088292-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088292-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088292-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088292-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088292-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088292-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088292-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088292-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088292-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088292-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088292-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088292-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088292-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088292-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088292-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088292-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088292-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088292-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088292-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088292-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088292-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088292-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088292-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088292-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088292-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088292-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088292-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088292-001AB1e64feba35796…

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 HYDROCHLORIDEStrides Pharma Science Limited51d3b181-0d15-4782-a966-feb137972b182026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088292
application number: ANDA088292
ndc (product): 64380-169

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-054Imipramine HydrochlorideImipramine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-054Imipramine HydrochlorideImipramine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-054Imipramine HydrochlorideImipramine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
60429-095Imipramine HydrochlorideImipramine HydrochlorideGolden State Medical Supply, In.cANDACurrent
60429-095Imipramine HydrochlorideImipramine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-095Imipramine HydrochlorideImipramine HydrochlorideGolden State Medical Supply, In.cANDACurrent
60429-095Imipramine HydrochlorideImipramine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63629-2208Imipramine HydrochlorideImipramine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2208Imipramine HydrochlorideImipramine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2208Imipramine HydrochlorideImipramine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8149Imipramine HydrochlorideImipramine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8149Imipramine HydrochlorideImipramine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8149Imipramine HydrochlorideImipramine HydrochlorideBryant Ranch PrepackANDACurrent
64380-169Imipramine HydrochlorideImipramine HydrochlorideStrides Pharma Science LimitedANDACurrent
64380-169Imipramine HydrochlorideImipramine HydrochlorideStrides Pharma Science LimitedANDACurrent
68151-2768Imipramine HydrochlorideImipramine HydrochlorideCarilion Materials ManagementANDACurrent