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PHENYLEPHRINE HYDROCHLORIDE	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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PHENYLEPHRINE HYDROCHLORIDE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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PHENYLEPHRINE HYDROCHLORIDE	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2014-06-27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N204300-001	VAZCULEP	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`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N204300-002	VAZCULEP	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2014-06-27	`84e616aacf4f…`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 2 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	ProPharma Distribution	386663e8-f1f6-cf14-e063-6394a90a68df	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	40fde50a-3cc0-4286-9b33-8f3912254c33	2025-12-18	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	SOLA Pharmaceuticals, LLC	bf264b20-6d00-495e-90c7-9172d4535ec7	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Quality Choice	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	a12e2e66-d2f3-47a6-a915-a309ae828d27	2025-12-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
QUALITY CHOICE	PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	14596551-dd82-46b3-8eb8-e69efaea105b	2025-12-04	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Provepharm Inc.	e1d3881f-fa9e-4d68-8ef0-9e03435fc292	2025-11-24	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
4 Way Fast Acting	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a8fc41c7-4425-41b8-b1c6-eb22ac054734	2025-11-12	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
ValuMeds Nasal Decongestant Phenylephrine HCl	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	21676b0c-6be2-464c-ae91-92e5f0d0087d	2025-11-06	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f454c289-5a31-4bd3-86a2-1281bf1ab14b	2025-10-31	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Better Living	PHENYLEPHRINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC	aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1	2025-10-29	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Publix	PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	f10e120d-f0b7-4c51-b29b-e8cdbb1456f3	2025-10-28	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	41eec9e9-6e94-15d4-e063-6394a90a98a2	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Extra Strength Sinus Relief Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	0d8a009c-30b5-4f12-90bd-f8aa1110243f	2025-10-14	Warnings	Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	InvaTech Pharma Solutions LLC	b8d360fa-0d80-f6a8-e053-2a95a90a8bd4	2025-10-01		Name fallback generic name: PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	Gland Pharma Limited	2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb	2025-09-18	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