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 1.

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PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204300-002	VAZCULEP	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204300-003	VAZCULEP	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204300-001	VAZCULEP	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP1	RLD, RS	2014-06-27	`8072bd15b7f6…`

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 1 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Lifestar Pharma LLC	1767c4b7-36a0-4e64-9091-2af22161402f	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Lifestar Pharma LLC	f43e4abd-0083-4fe5-9c27-0ba9245e5138	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
up and up	PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b42775ae-44fe-487e-b9ca-21d9687020a9	2026-07-29	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 107, LLC	6d59ee85-08e5-452d-a09a-35fcc2a82b75	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Neo-Synephrine Severe	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	54edaff7-d241-dc90-e063-6294a90ac64d	2026-06-23	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
NO DRIP NASAL	PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	7a866cdf-1c0c-403a-afc8-0e99e0ce81aa	2026-06-22	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	30f6d588-ad80-4348-a45f-77337e067bca	2026-06-19	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	694a3116-1b75-42cd-bbcf-d19831c2d796	2026-06-01	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	90fae0fa-da07-4ea8-bdbd-39c2ed99ae59	2026-05-06	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	5d8b980f-0011-41e3-a881-ad10fe399079	2026-05-06	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Caplin Steriles Limited	1b9f1d54-ea46-49c8-a33e-c94a61bc0460	2026-04-28	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Par Health USA, LLC	d92631a6-bae8-493b-b4df-c563346607a8	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	19879fc8-4962-4c6e-87ed-b874d1d564af	2026-04-01	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Biorphen	PHENYLEPHRINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	2f715e4e-b269-b935-d2c9-003cb29770be	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Medi-First Plus Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	20f58b0b-c123-477f-a62c-fa5423e23f93	2026-03-06	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
nasal	PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	1c3dc4e6-452b-4c84-b53c-426cf9ae8f03	2026-02-12	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	4bab505d-d5c8-8c3b-e063-6394a90ad18a	2026-02-01	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Baxter Healthcare Corporation	74192a42-0ff7-443b-9d8a-3096ef5c8e43	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Eugia US LLC	c2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad4d74a8-a762-4378-9016-f7c83421073e	2025-12-26	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE

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