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PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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N204300-001	VAZCULEP	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`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N204300-002	VAZCULEP	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`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 3 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medi-First Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	9654f5cd-74d7-44a2-9674-666d1e94ffa7	2025-09-08	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Green Guard Allergy 2 Relief	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	16fddca9-a66b-41e6-9423-eaf091d3971e	2025-09-08	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Medique Medi-Phenyl	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	d7d62ac1-1333-4366-884b-26537766ce38	2025-09-08	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Crane Safety Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Crane Safety LLC	968baa85-ce0e-0c3d-e053-2995a90ac03a	2025-09-08	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc.,	869917f1-ae26-40cd-d332-5a31a796b877	2025-08-31	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
ReVIVOL-XR	PHENYLEPHRINE HYDROCHLORIDE	Unipack LLC	2950fe83-a2a4-4ed4-b645-69d6fd2381ae	2025-07-13	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	b54a0c59-e5e4-4fd7-ba91-c991ce87b148	2025-07-04	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Henry Schein, Inc.	db313f72-a6bb-444f-949f-19b4aa6f61c0	2025-06-18	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7	2025-05-15	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	fad93be4-32dd-44c1-a20f-2b0bb3b41929	2025-05-01	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	96d2e0e7-2de0-4660-9ffd-9edb2ad224d8	2025-04-18	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Alcon Laboratories, Inc.	cacbb3fd-1c03-4523-a1bf-0ccc4be102ef	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Somerset Therapeutics, LLC	170e63f1-23f4-4839-ab89-b81832d94a56	2025-03-05	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Bi-Mart	d208cb6f-e142-4aa3-959b-e6b601df76c1	2025-03-01	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Caplin Steriles Limited	1b3eec91-5be5-4010-bf92-4c3e72b39b2a	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	4099cef4-44b1-ae3d-e063-6394a90aefac	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Civica, Inc.	7a23ed28-3912-4398-b660-bf9ec3ee3926	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
good neighbor pharmacy nasal four	PHENYLEPHRINE HYDROCHLORIDE	Amerisource Bergen	a3d637dc-d957-458c-8a75-f948601a31aa	2024-11-14	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Sudafed PE Sinus Congestion	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ca08917-1a75-4365-8520-c083e6a4225a	2024-11-08	Warnings	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