Application 215483

Type: ANDA
Sponsor: JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 25MG BASE	No	No
003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215483-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14
A215483-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14
A215483-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14
A215483-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14
A215483-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215483-001	AB
A215483-002	AB
A215483-003	AB
A215483-004	AB
A215483-005	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 4 · 160 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	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-03-14	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A215483-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215483-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215483-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215483-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215483-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215483-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215483-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215483-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215483-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215483-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215483-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215483-005	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 5 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Appco Pharma LLC	abf4c515-8888-4733-80a0-fd4e1cdb84a2	2021-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	e98f371e-f7fe-4c8f-9491-6eb4c53d43ad	2021-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Contract Pharmacal Corp.	abbf7078-a012-4e1a-e053-2995a90a792d	2020-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	10d9eba6-30d1-448a-8d92-a1a02df03303	2017-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
PRUDOXIN	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ca53346b-8ab3-4722-98f6-cf272706d3fa	2017-06-29	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Zonalon	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	5f302247-525e-4acc-852b-00eb1d79af4b	2017-06-14	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	b4771ea7-c19b-4182-bb23-c1473ab583fa	2017-05-24	Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-982	Doxepin Hydrochloride	Doxepin Hydrochloride	Quality Care Products, LLC	ANDA	Current
59746-700	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-700	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-701	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-701	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-702	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-702	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-703	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-703	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-704	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-704	Doxepin Hydrochloride	Doxepin Hydrochloride	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
72189-388	Doxepin HCL	Doxepin HCL	Direct_Rx	ANDA	Current