Application 214548

Type: ANDA
Sponsor: UNICHEM

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
A214548-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19
A214548-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19
A214548-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19
A214548-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19
A214548-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19
A214548-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214548-001	AB
A214548-002	AB
A214548-003	AB
A214548-004	AB
A214548-005	AB
A214548-006	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 · 210 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	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A214548-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214548-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214548-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214548-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214548-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214548-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-004	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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	6dc9d113-1156-43ec-a7eb-253c2ff6bcfa	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	e42225f5-44bd-451e-98a1-aa3877457733	2023-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	1a622039-0a79-407c-8f15-2ea0c5844136	2023-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8746c047-51b9-4040-aeec-cd1f5b6eb3d4	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548

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 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-419	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-419	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-420	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-420	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-421	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-421	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-422	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-422	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-423	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-423	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-424	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-424	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-6179	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6313	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6315	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	A-S Medication Solutions	ANDA	Current
60760-556	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
68071-2796	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2843	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8218	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current