FDA.reportPublic FDA data

Application 088622

Type
ANDA
Sponsor
WATSON LABS

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
A088622-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02

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 22:38:342026-08A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-0284e616aacf4f…
2026-08-18 06:07:402026-07A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-023f01610625f2…
2019-09-15 20:21 UTC2019-09A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088622-001AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1984-03-02f41ea6bd6efb…

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 2 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC50375dab-97fe-8c84-e063-6394a90a60b22026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC500f239c-0460-a22b-e063-6294a90a1ba62026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack9f9d6495-47ff-4dcf-9643-ebd5cd7499cb2026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDELifestar Pharma LLC67e31675-1da2-4acf-84ac-77522b02f0b92026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAurobindo Pharma Limited8085a37f-3c76-4f74-aab3-9a929a7eb1c22026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions53f4f83c-4bfd-43d6-9bb8-82c21ed2864f2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9d00b912-69be-4d9a-8c81-42cfc9bf6e092026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.451b8742-8b3c-4335-9075-c1d8313cd3d02026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa82026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.8b10ac1a-cf66-4efa-9abc-498b2f8a16132026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.cf03c1a1-cbd5-47dc-a5e8-70ec32b71cb12026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b2f822aa-23c0-4833-afc8-f5a611b9ad5a2026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5dd07852-43a5-415c-863e-1202f82b56542026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e262026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions5fe84552-9650-42e4-9870-add97b46dfe12026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack3893689b-f794-4dfd-9bd4-3fa53069e35f2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.147d2f8f-842d-4f09-86b0-a66edce277782026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.54485767-d7c5-4927-ae52-08537a7a91e82026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY485b87c3-2a51-133b-e063-6294a90a95c32026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC43450e62-d8c1-b39e-e063-6294a90a42ee2026-01-02Boxed 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.