FDA.reportPublic FDA data

Application 088888

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A088888-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-2684e616aacf4f…
2026-08-18 06:07:402026-07A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-263f01610625f2…
2019-09-15 20:21 UTC2019-09A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088888-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-09-26f41ea6bd6efb…

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 4 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9110367c-4104-4836-8af3-649f86b0b3ea2025-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEMajor Pharmaceuticals29ec1221-04d8-4b21-822e-2779fcaae62c2025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions85574987-8d31-4bd0-b829-bb154ef212f52025-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthstar Rx LLC.8ed28f42-e41a-45ca-a86f-849ebeb6ab802025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.9c6e0e05-b579-4fae-b768-e1a664c39bb82025-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESandoz Inc705a2bae-031d-4218-82fe-4346542c0baa2025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35a6e911-507a-ef0d-e063-6294a90a07e12025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35a7ce7d-4a29-e3f0-e063-6294a90ad66f2025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack2bda8478-f5ab-440a-a8a3-61ebc57213692025-05-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack86bad1a5-48c3-4a8a-970f-8fdbda078b4e2025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDERising Pharma Holdings, Inc.a219a68e-7ce5-4e9d-a0de-ec76960040f62025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.73669354-babc-4687-a4fe-ad0fc1f863ba2025-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsbbbd535d-0bce-469e-917f-70a6ebd2f0072025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions69c7a0bd-93d0-40fe-a6d3-f41986b802b42025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAvPAKf5c5f3b6-e92b-1120-e053-2995a90ae8fa2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAvPAKfd771b4b-c7ae-8e69-e053-6294a90a21202025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC082b620f-8085-d205-e063-6294a90ac6de2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98d25a7-6b47-38a9-e053-6394a90a541d2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf78102eb-cbeb-801a-e053-6294a90ab8802024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC19b0c015-c07f-63b7-e063-6394a90a60602024-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.