Application 213999

Type: ANDA
Sponsor: MANKIND PHARMA

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 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
A213999-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19
A213999-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19
A213999-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19
A213999-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19
A213999-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19
A213999-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213999-001	AB
A213999-002	AB
A213999-003	AB
A213999-004	AB
A213999-005	AB
A213999-006	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
2026-08-18 06:07:40	2026-07	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`

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
2026-08-18 06:07:40	2026-07	A213999-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213999-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213999-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213999-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-004	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	500f239c-0460-a22b-e063-6294a90a1ba6	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	9f9d6495-47ff-4dcf-9643-ebd5cd7499cb	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Lifestar Pharma LLC	67e31675-1da2-4acf-84ac-77522b02f0b9	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999 ndc (product): 70756-202 ndc (product): 70756-205 ndc (product): 70756-201 ndc (product): 70756-204 ndc (product): 70756-203 ndc (product): 70756-206
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f67d6f73-88d7-2031-e053-2995a90a3b09	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f8236cd1-1b60-4a66-e053-6294a90afeb0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f7e4ac7b-17bc-dae8-e053-6394a90a9cb6	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline HCL	AMITRIPTYLINE HCL	Direct_Rx	23ab2afe-06c1-fa61-e063-6394a90abcf8	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999

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
70756-201	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-202	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-203	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-204	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-205	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-206	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	Lifestar Pharma LLC	ANDA	Current