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 2 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	Safecor Health, LLC	a2297f75-c498-419b-aa29-057271313a7f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ede17e6-19e9-455c-ad16-8029a590735c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d2a91b99-513d-4894-ad6d-02d2028a2290	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	e6a4cb10-1928-4abe-8797-404c9ddc37dd	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	d5df4beb-8048-4b83-aa59-19876437001d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1496dfc1-de50-471c-be87-1f1e2b70ab5a	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	e0460c02-3dae-4b19-845c-2ffcfb587f6d	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Redpharm Drug	37451a61-ccb1-57b3-e063-6294a90a2592	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Chartwell RX, LLC	33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Ajanta Pharma USA Inc.	1513c98c-e7ef-4009-b932-6757048bb86a	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8f7e9677-cc84-414b-8eb8-33993d285bb3	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	09a70f17-f934-4b4b-9277-6351d906ab47	2025-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	55f7d7b5-b747-49ac-9bf0-1510987b0291	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1533343b-f1ed-4c3a-bb36-23a748452b05	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	94ee3c14-0ccc-4329-b012-63679a699a67	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	First Nation Group, LLC	3d4f84a4-07a1-4d0e-85f5-dcd43b236a42	2025-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	NorthStar RxLLC	03cef3a6-a63d-4082-a491-451b24227d9d	2025-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Major Pharmaceuticals	df3b6be0-6a64-4174-b351-dab2061f290e	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	89ed6385-cf6a-458e-81ea-c7f3fead41c5	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aurobindo Pharma Limited	f3c242dd-426e-4c69-8f21-2645361d5f27	2025-09-01	Boxed warning, 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