Application 200179

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STAXYN	VARDENAFIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	Yes

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

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
N200179-001	STAXYN	VARDENAFIL HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200179-001	8613950	2028-12-23		Drug product	2014-01-22

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 · 41 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UTC	2026-02	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	N200179-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200179-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200179-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200179-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200179-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200179-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200179-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200179-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200179-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200179-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200179-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200179-001	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`cb3db0bc1861…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Lannett Company, Inc.	2782efed-6198-47b9-81ac-3e255e2ab7f6	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	80c4793d-e19e-10f0-e053-2991aa0a4620	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Chartwell RX, LLC	57a0c163-a5e8-4c6e-a4ea-114cb2668407	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	083a3282-254f-4042-b0eb-70f76a279f10	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	6d2859a7-6def-455f-856b-9db86b1fd355	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	666a622b-2464-4c55-8c90-0f1cc85bc1e9	2025-10-28	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	8791997d-3b86-45af-988f-808e259da506	2025-10-28	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	3b03952b-d404-09cd-e063-6294a90a8b2c	2025-07-28	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	d8a5cc4b-9d9d-43af-9ee4-57381aa6368a	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	31be68b0-ac7e-42d0-9435-1f0a329b63d8	2024-04-03	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e593ab58-70a4-4095-8091-16a4b6d49e4d	2023-12-08	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	a38de6e1-21ca-4ebe-a3c7-6f849cf8b675	2023-04-10	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	d2dce236-257e-44b6-93a9-9f0280257c6a	2023-03-22	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2023-01-24	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	09366eb3-93e0-41d9-bf9a-24335ed3555f	2021-01-27	Warnings, Adverse reactions	Name fallback generic name: VARDENAFIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0822	Staxyn	vardenafil hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0822	Staxyn	vardenafil hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0822	Staxyn	vardenafil hydrochloride	GlaxoSmithKline LLC	NDA	Current
0173-0822	Staxyn	vardenafil hydrochloride	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74057	SUPPL	2023-04-25
74055	SUPPL	2023-04-25
49573	SUPPL	2017-08-29
49448	SUPPL	2017-08-17
49245	SUPPL	2017-08-04
49239	SUPPL	2017-08-04
40013	SUPPL	2015-09-23
32014	SUPPL	2015-09-17
18952	SUPPL	2014-05-02
9807	SUPPL	2014-04-30
40012	SUPPL	2013-08-06
9806	SUPPL	2013-08-05
43343	ORIG	2011-01-04
40011	ORIG	2010-06-24
32013	ORIG	2010-06-21