Application 212654

Type: ANDA
Sponsor: UPSHER SMITH LABS

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 42.

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
A212654-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07
A212654-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29
A212654-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29
A212654-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29
A212654-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29
A212654-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212654-001	AB
A212654-002	AB
A212654-003	AB
A212654-004	AB
A212654-005	AB
A212654-006	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 6 · 208 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
2026-08-18 06:07:40	2026-07	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212654-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212654-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212654-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212654-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-004	AB	1	`03ed91905a0d…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	35aa7ab3-321a-97f7-e063-6294a90a91e2	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	16364b31-4b8b-481a-a553-e8974c0e557c	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	ce87013b-bf4a-47d1-9808-7cb8290feb23	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9d00b912-69be-4d9a-8c81-42cfc9bf6e09	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	5fe84552-9650-42e4-9870-add97b46dfe1	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	3893689b-f794-4dfd-9bd4-3fa53069e35f	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	085baad2-d1c7-499e-b553-7477befd04d0	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	ace6748d-735c-4e6e-b327-a20101fd23d4	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	56379133-cd11-4dff-b511-7cdfc9a360ca	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	33807ee6-8443-4613-8bbe-d66f6010fc60	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	db4d83b8-3ce7-433e-b32a-a8dc2f44b909	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	63cd768c-4ed1-47af-901a-3835919ca4d9	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f58	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	61b29703-cfc2-45c7-ae24-7bf3b77e8587	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	d46ff585-7082-4a7c-a88f-2acf3be0f1d5	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-1220	Amitriptyline hydrochloride	Amitriptyline hydrochloride	Upsher-smith Laboratories, LLC	ANDA	Current
0832-1221	Amitriptyline hydrochloride	Amitriptyline hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1222	Amitriptyline hydrochloride	Amitriptyline hydrochloride	Upsher-smith Laboratories, LLC	ANDA	Current
0832-1223	Amitriptyline hydrochloride	Amitriptyline hydrochloride	Upsher-smith Laboratories, LLC	ANDA	Current
0832-1224	Amitriptyline hydrochloride	Amitriptyline hydrochloride	Upsher-smith Laboratories, LLC	ANDA	Current
0832-1225	Amitriptyline hydrochloride	Amitriptyline hydrochloride	Upsher-smith Laboratories, LLC	ANDA	Current