Application 202446

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202446-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04
A202446-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04
A202446-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04
A202446-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04
A202446-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04
A202446-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202446-001	AB
A202446-002	AB
A202446-003	AB
A202446-004	AB
A202446-005	AB
A202446-006	AB

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202446-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202446-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AB	1	`b8a1b40f171c…`

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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	e3afe026-7072-0a7d-e053-2995a90a52d4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
Amitriptyline HCL	AMITRIPTYLINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	ca66c2fc-6724-f4cd-e053-2995a90a42cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446 ndc (product): 80425-0172
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446 ndc (product): 71335-0566
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	58ff9a82-5de6-a1b0-e053-2991aa0a84ba	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a5a4040-5395-54ac-e053-2991aa0aa4ab	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9440dd10-2f0d-42a7-a037-3ab8729708f6	2023-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	df5aee40-ffa9-4cf3-ab5f-30253f43092b	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 4 of 4 · 254 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0566	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0566	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
72189-309	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	DirectRx	ANDA	Current
76420-237	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-238	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
76420-239	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Asclemed USA, Inc.	ANDA	Current
80425-0137	Amitriptyline	Amitriptyline HCl 50mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0137	Amitriptyline HCL	Amitriptyline HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0137	Amitriptyline HCL	Amitriptyline HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0172	Elavil	Amitriptyline 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0172	Elavil	Amitriptyline 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0172	Amitriptyline HCL	Amitriptyline HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0172	Amitriptyline HCL	Amitriptyline HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0172	Amitriptyline HCL	Amitriptyline HCL	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current