Application 089399

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG	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 1.

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
A089399-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14
A089399-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14
A089399-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14
A089399-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14
A089399-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14
A089399-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089399-001	AB
A089399-002	AB
A089399-003	AB
A089399-004	AB
A089399-005	AB
A089399-006	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 · 246 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
2026-02-19 14:30 UTC	2026-02	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089399-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089399-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-004	AB	1	`2680178bc6a6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	04e1c5f8-de7e-8ce7-e063-6394a90acc57	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4e520c63-1cf6-40f6-a51c-3f9b0e181342	2025-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399 ndc (product): 57664-690 ndc (product): 57664-688 ndc (product): 57664-687 ndc (product): 57664-692 ndc (product): 57664-691 ndc (product): 57664-689
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	541ba74a-babb-4731-a5ef-fe7c18992c0b	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399 ndc (product): 71335-1254
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	dcdeb999-412e-475f-a21d-2e0ac42d136e	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399 ndc (product): 71335-1256
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	25832051-837b-4682-8548-5ab9a1b7cdac	2023-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4e0f3b15-3621-48a1-9f2b-b0a373920360	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-687	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-687	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-687	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-687	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-688	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-688	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-688	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-688	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-689	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-689	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-689	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-689	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-690	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-690	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-690	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-690	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-691	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-691	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-691	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-691	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-692	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-692	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-692	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-692	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
71335-1254	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1254	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1256	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1256	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Bryant Ranch Prepack	ANDA	Current