FDA.reportPublic FDA data

Application 218389

Type
ANDA
Sponsor
UNIQUE PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL75MGNoNo
005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDETABLET;ORAL100MGNoNo
006AMITRIPTYLINE 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218389-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-23
A218389-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-23
A218389-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-23
A218389-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-23
A218389-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-23
A218389-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A218389-001AB
A218389-002AB
A218389-003AB
A218389-004AB
A218389-005AB
A218389-006AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218389-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A218389-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A218389-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A218389-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A218389-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A218389-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-2384e616aacf4f…
2026-08-18 06:07:402026-07A218389-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218389-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A218389-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2025-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2025-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2025-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2025-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2025-06-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2025-06-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218389-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218389-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218389-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A218389-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A218389-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A218389-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A218389-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218389-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218389-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218389-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218389-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218389-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218389-006AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218389-006AB1a50c72e98297…

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 6 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions00d11130-c9ae-4258-9746-9763bc5deb842023-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions5e8c8c5f-4964-4642-ad4b-69a75b2c8a022023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsd22879c5-925a-42e0-9d48-55a4221929832023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LP6dc9d113-1156-43ec-a7eb-253c2ff6bcfa2023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25832051-837b-4682-8548-5ab9a1b7cdac2023-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e0f3b15-3621-48a1-9f2b-b0a3739203602023-09-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPe42225f5-44bd-451e-98a1-aa38774577332023-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions1a622039-0a79-407c-8f15-2ea0c58441362023-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8746c047-51b9-4040-aeec-cd1f5b6eb3d42023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9440dd10-2f0d-42a7-a037-3ab8729708f62023-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AMITRIPTYLINE HYDROCHLORIDE
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECentaur Pharmaceuticals Private Limited3d113e43-c694-427f-8b77-66be36a823742022-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amitriptyline Hydrochloride
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPdf5aee40-ffa9-4cf3-ab5f-30253f43092b2022-05-02Boxed 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.