FDA.reportPublic FDA data

Application 088885

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL50MGNoNo

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
A088885-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / 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 22:38:342026-08A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-2684e616aacf4f…
2026-08-18 06:07:402026-07A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-263f01610625f2…
2019-09-15 20:21 UTC2019-09A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-09-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088885-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / 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 5 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack3d9292dc-49a0-46f4-9980-3e8d57121d432024-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8c9f605f-ac13-442f-af4d-ea11102474de2024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC20aff9dc-98a7-6061-e063-6394a90a2aab2024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackac1a7640-58d7-494d-94c8-27911470bf592024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack76d3f4fd-4603-4cfc-94ab-2e62c0bdae752024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepacka726f82c-1018-44ee-ab1f-f5d34e6b388e2024-08-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack6a176cd7-7c13-440e-b6bb-dc2fab3f2a122024-08-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e78e304-00e8-7cb3-e063-6294a90a87ad2024-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.58ff9a82-5de6-a1b0-e053-2991aa0a84ba2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5a5a4040-5395-54ac-e053-2991aa0aa4ab2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsb793f1f8-c1f9-46f0-8156-1a4957db3a1f2024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions0067b698-ee1d-4524-b1cc-af1028d137362024-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackc707a873-6b67-478f-aa3c-d206a59cbe6d2024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack4ce78bf6-61ec-435f-9af5-c86df440892a2024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC18ff2901-08fd-37f0-e063-6394a90a1ad22024-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPce665435-b2f1-4fcd-ae20-4f372f3760952024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAsclemed USA, Inc.776d2c2c-d897-4da1-a99a-b4324e1f864f2024-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LP61133866-b01c-4278-93fb-4564c1b56e542024-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack541ba74a-babb-4731-a5ef-fe7c18992c0b2024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackdcdeb999-412e-475f-a21d-2e0ac42d136e2024-01-15Boxed 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.