Application 070791

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
A070791-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13
A070791-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13
A070791-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13
A070791-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13
A070791-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070791-001	AB
A070791-002	AB
A070791-003	AB
A070791-004	AB
A070791-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-001	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-002	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1986-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-003	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1986-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1986-05-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070791-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070791-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070791-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070791-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070791-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070791-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070791-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070791-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070791-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070791-005	AB	1	`5bbf6a4d5a75…`

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
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	c577af7c-2405-4454-a169-5b6a4fa0c7bf	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791 ndc (product): 63629-5033
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Safecor Health, LLC	a2297f75-c498-419b-aa29-057271313a7f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ede17e6-19e9-455c-ad16-8029a590735c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791 ndc (product): 55289-370
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d2a91b99-513d-4894-ad6d-02d2028a2290	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1533343b-f1ed-4c3a-bb36-23a748452b05	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791 ndc (product): 0378-5375 ndc (product): 0378-6410 ndc (product): 0378-4250 ndc (product): 0378-3125 ndc (product): 0378-1049
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Institutional Inc.	137a953b-3c48-405f-86a6-ff778cb7f5f2	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791 ndc (product): 51079-436 ndc (product): 51079-437 ndc (product): 51079-438 ndc (product): 51079-651
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	10d9eba6-30d1-448a-8d92-a1a02df03303	2017-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070791 application number: ANDA070791 ndc (product): 43353-331 ndc (product): 43353-329

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 85 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1049	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1049	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1049	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3125	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3125	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3125	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4250	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4250	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4250	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5375	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5375	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5375	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6410	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6410	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6410	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
21695-943	Doxepin Hydrochloride	Doxepin Hydrochloride	Rebel Distributors Corp	ANDA	Current
35356-424	Doxepin Hydrochloride	doxepin hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-650	Doxepin Hydrochloride	doxepin hydrochloride	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-650	Doxepin Hydrochloride	doxepin hydrochloride	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
43353-329	Doxepin Hydrochloride	doxepin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-331	Doxepin Hydrochloride	doxepin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-775	Doxepin Hydrochloride	doxepin hydrochloride	Medsource Pharmaceuticals	ANDA	Current
45865-775	Doxepin Hydrochloride	doxepin hydrochloride	Medsource Pharmaceuticals	ANDA	Current
45865-849	Doxepin Hydrochloride	doxepin hydrochloride	Medsource Pharmaceuticals	ANDA	Current
49999-190	Doxepin Hydrochloride	doxepin hydrochloride	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-0278	Doxepin Hydrochloride	doxepin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0278	Doxepin Hydrochloride	doxepin hydrochloride	A-S Medication Solutions	ANDA	Current
51079-436	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-436	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-437	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-437	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-438	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-438	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-651	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-651	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Institutional Inc.	ANDA	Current
52959-662	Doxepin Hydrochloride	doxepin hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
53217-070	Doxepin Hydrochloride	doxepin hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55289-018	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-258	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-370	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-370	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-370	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-370	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-370	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-370	Doxepin Hydrochloride	doxepin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60429-966	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-966	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-966	Doxepin Hydrochloride	doxepin hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-967	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-967	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-967	Doxepin Hydrochloride	doxepin hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-968	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-968	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-968	Doxepin Hydrochloride	doxepin hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-969	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-969	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-969	Doxepin Hydrochloride	doxepin hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-970	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-970	Doxepin Hydrochloride	doxepin hydrochloride	GSMS, Incorporated	ANDA	Current
60429-970	Doxepin Hydrochloride	doxepin hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
61919-081	doxepin hydrochloride	doxepin hydrochloride	DIRECT RX	ANDA	Current
61919-567	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	DIRECT RX	ANDA	Current
63629-3221	Doxepin Hydrochloride	doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-3221	Doxepin Hydrochloride	doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5033	Doxepin Hydrochloride	doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5033	Doxepin Hydrochloride	doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5033	Doxepin Hydrochloride	doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current
64725-5375	Doxepin Hydrochloride	doxepin hydrochloride	TYA Pharmaceuticals	ANDA	Current
67046-131	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67046-132	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67046-133	Doxepin Hydrochloride	Doxepin Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
68071-2314	Doxepin Hydrochloride	doxepin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2314	Doxepin Hydrochloride	doxepin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1488	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1488	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1525	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1532	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1532	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1555	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1555	Doxepin Hydrochloride	doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18341	SUPPL	2014-09-05