Application 204300

Type: NDA
Sponsor: AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VAZCULEP	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/ML (10MG/ML)	Yes	Yes
002	VAZCULEP	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	50MG/5ML (10MG/ML)	Yes	Yes
003	VAZCULEP	PHENYLEPHRINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	100MG/10ML (10MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204300-001	VAZCULEP	PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27
N204300-002	VAZCULEP	PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27
N204300-003	VAZCULEP	PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27

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 · 129 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
2026-09-14 22:38:34	2026-08	N204300-001	VAZCULEP	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204300-002	VAZCULEP	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204300-003	VAZCULEP	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204300-001	VAZCULEP	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204300-002	VAZCULEP	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204300-003	VAZCULEP	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N204300-001	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204300-002	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204300-003	AP1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204300-001	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204300-002	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204300-003	AP1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204300-001	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204300-002	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204300-003	AP1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204300-001	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204300-002	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204300-003	AP1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204300-001	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204300-002	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204300-003	AP1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204300-001	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204300-002	AP1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204300-003	AP1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204300-001	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204300-002	AP1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204300-003	AP1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204300-001	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204300-002	AP1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204300-003	AP1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204300-001	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204300-002	AP1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204300-003	AP1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204300-001	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204300-002	AP1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204300-003	AP1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204300-001	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204300-002	AP1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204300-003	AP1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204300-001	AP1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204300-002	AP1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204300-003	AP1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204300-001	AP1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204300-002	AP1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204300-003	AP1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204300-001	AP1	1	`5d02ea3f76ae…`

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 4 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
CareOne Fast Acting Nasal	PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5	2024-10-24	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
dg health nasal four	PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ceeeb016-8e46-40b8-9923-8a4270475f45	2024-10-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	744da574-dfc9-4a22-8983-2ee15be2ea84	2024-10-04	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Topcare Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	99bc8829-167b-4cf8-8421-57da369f24cd	2024-10-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
basic care nasal	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	858648f6-f454-4008-9ea8-ad060c217833	2024-10-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
equaline nasal	PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	67fdd277-7a7a-4404-8ca2-39802c46405f	2024-09-20	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Good Sense Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	930469c1-384c-4440-b3e6-9dcd674871c4	2024-09-19	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
nasal	PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	8db7df1c-46b5-49bd-9002-50b12d58001a	2024-09-13	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	95ef1819-edc3-4dda-8514-85b61538cc72	2024-09-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	NorthStar RxLLC	ea70aafe-f3ba-471a-8c8f-f533c0a3c27c	2024-09-03	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	NorthStar RxLLC	3ce681eb-8580-49bf-962a-68a576fddd57	2024-09-02	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Leading Pharma, LLC	7543f7e8-fd5f-46d5-a310-ebae71becf44	2024-08-23	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Good Sense Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	A-S Medication Solutions	5396a9cf-16eb-4628-9432-f49c67ffe2ce	2024-06-25	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal	PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	fea71cb9-e044-4729-ad26-1db0cdb9dd11	2024-05-14	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
NASAL and SINUS DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	JHK Inc dba American Safety & First Aid	63e51305-2575-49c4-9fda-7b3e1b4b6ede	2024-04-26	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c3f358dd-4a36-4808-9943-e01f88604be5	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hainan Poly Pharm. Co., Ltd.	8d6973c4-4a69-4d49-9da7-d2a00df83ecb	2024-03-19	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c600fe14-40b6-2b5a-e053-2a95a90aff98	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	0bb7af81-62ec-4ae7-8055-89453f7a161d	2023-12-30	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE 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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-4000	Vazculep	Phenylephrine Hydrochloride	Exela Phrama Sciences, LLC	NDA	Current
51754-4010	Vazculep	Phenylephrine Hydrochloride	Exela Phrama Sciences, LLC	NDA	Current
51754-4020	Vazculep	Phenylephrine Hydrochloride	Exela Phrama Sciences, LLC	NDA	Current
68001-331	Vazculep	Phenylephrine Hydrochloride	BluePoint Laboratories	NDA	Current
71872-7042	Vazculep	Phenylephrine Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current
71872-7042	Vazculep	Phenylephrine Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current
76014-004	Vazculep	Phenylephrine Hydrochloride	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-004	Vazculep	Phenylephrine Hydrochloride	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-004	Vazculep	Phenylephrine Hydrochloride	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-004	Vazculep	Phenylephrine Hydrochloride	Avadel Legacy Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62584	SUPPL	2020-04-17
62281	SUPPL	2020-03-24
60619	SUPPL	2019-10-22
60611	SUPPL	2019-10-21
32541	SUPPL	2015-05-29
44898	ORIG	2015-05-14
43461	ORIG	2015-05-14
40372	ORIG	2014-06-30
32540	ORIG	2014-06-30