FDA.reportPublic FDA data

Application 088635

Type
ANDA
Sponsor
WATSON LABS

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
A088635-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / 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 22:38:342026-08A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-0284e616aacf4f…
2026-08-18 06:07:402026-07A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-023f01610625f2…
2019-09-15 20:21 UTC2019-09A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1984-03-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088635-001AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / 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 3 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCe3afe026-7072-0a7d-e053-2995a90a52d42026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCf67d6f73-88d7-2031-e053-2995a90a3b092026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCf8236cd1-1b60-4a66-e053-6294a90afeb02026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCf7e4ac7b-17bc-dae8-e053-6394a90a9cb62026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC471f3a17-baaa-cc35-e063-6294a90aed962025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions085baad2-d1c7-499e-b553-7477befd04d02025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsace6748d-735c-4e6e-b327-a20101fd23d42025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC4616c2be-03a5-4279-e063-6294a90ac0522025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvagen Pharma Ltd651bd090-a420-4dd8-89b0-4cb766c144c22025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAmerican Health Packaging98cc0bf3-ae5b-47cc-992f-9157fed7c3f42025-11-25Boxed warning, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.15c2afe3-3309-4abc-87d1-f3eab8d89b202025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.43454445-b9cf-1378-e063-6294a90a1cc62025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAiPing Pharmaceutical, Inc.33807ee6-8443-4613-8bbe-d66f6010fc602025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEZydus Lifesciences Limited4159b10e-f589-486c-969d-9b4544b098b52025-10-04Name fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackdb4d83b8-3ce7-433e-b32a-a8dc2f44b9092025-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack63cd768c-4ed1-47af-901a-3835919ca4d92025-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCd46ff585-7082-4a7c-a88f-2acf3be0f1d52025-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEGolden State Medical Supply, Inc.04e1c5f8-de7e-8ce7-e063-6394a90acc572025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1523a2b4-f9d6-4d3c-a370-df579ed369112025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d7bfeb47-2482-4217-b522-df44444991332025-07-15Boxed 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.