Application 020126

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZONALON	DOXEPIN HYDROCHLORIDE	CREAM;TOPICAL	5%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020126-001	ZONALON	DOXEPIN HYDROCHLORIDE	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020126-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020126-001	ZONALON	5%	CREAM / TOPICAL	AB	RLD, RS	1994-04-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020126-001	ZONALON	5%	CREAM / TOPICAL		RLD, RS	1994-04-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020126-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020126-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020126-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020126-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020126-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020126-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020126-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020126-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020126-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020126-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020126-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020126-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020126-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020126-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020126-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020126-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020126-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020126-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020126-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020126-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020126-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020126-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020126-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020126-001	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRUDOXIN	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ca53346b-8ab3-4722-98f6-cf272706d3fa	2017-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020126 application number: NDA020126 ndc (product): 0378-8130
Zonalon	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	5f302247-525e-4acc-852b-00eb1d79af4b	2017-06-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020126 application number: NDA020126 ndc (product): 0378-8123
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	b4771ea7-c19b-4182-bb23-c1473ab583fa	2017-05-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020126 application number: NDA020126 ndc (product): 0378-8117

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8117	Doxepin Hydrochloride	Doxepin Hydrochloride	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8123	Zonalon	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	NDA	Current
0378-8130	PRUDOXIN	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	NDA	Current
40076-511	PRUDOXIN	doxepin hydrochloride	Prestium Pharma, Inc.	NDA	Current
40076-715	Zonalon	doxepin hydrochloride	Prestium Pharma, Inc.	NDA	Current
40085-716	Doxepin Hydrochloride	Doxepin Hydrochloride	Renaissance Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
70518-0865	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0865	Doxepin Hydrochloride	Doxepin Hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58714	SUPPL	2019-05-15
58711	SUPPL	2019-05-15
57397	SUPPL	2019-02-01
2049	SUPPL	2004-07-01
12238	SUPPL	2003-04-04