Application 007935

Type: NDA
Sponsor: DELCOR ASSET CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PHENERGAN	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PHENERGAN	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	PHENERGAN	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N007935-002	PHENERGAN	PROMETHAZINE HYDROCHLORIDE	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N007935-003	PHENERGAN	PROMETHAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N007935-004	PHENERGAN	PROMETHAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N007935-003	PHENERGAN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N007935-004	PHENERGAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007935-002	PHENERGAN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`

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 5 · 92 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenergan	PROMETHAZINE HCL	Direct_Rx	eec705f7-123a-7926-e053-2a95a90af46d	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Phenergan
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	7fa840ad-10e7-4faf-9325-451648604161	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	adb04635-584f-4fef-98ca-2574be312a73	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Chartwell RX, LLC	2ca17cd4-460e-4d54-8c53-a58a2b80e5cb	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	f6ca1097-1c75-c682-e053-6294a90a2bd6	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	075f052e-7f38-7f75-e063-6394a90a512b	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	0b5734b8-6a52-44ff-ac29-9a91a4335394	2025-12-20	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ProPharma Distribution	38673af1-112e-9ddd-e063-6294a90af465	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	d32ea9db-11d4-400d-b7ef-dd0ec01b796d	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	ProPharma Distribution	45b09a50-dab2-e83d-e063-6394a90aa813	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride	PROMETHAZINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP	69934bbb-922c-4752-b253-f2f07340de8d	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	46b869e2-9305-43ae-bb15-919a6d09b6ff	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	e5d2156d-1f66-4fdf-a3ae-5e1325218c8b	2025-11-21	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	57b4bf23-c563-4357-9dcf-066cbc1280e4	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	e16238dc-9292-49ac-b80f-8afeccb88bc5	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97	2025-10-20	Boxed warning, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d766cf7-a21c-4eaf-bbdc-00f2939ef19a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43995	ORIG	2006-04-26
32954	SUPPL	2004-11-15
43	SUPPL	2004-11-15
136	SUPPL	2002-12-26
42	SUPPL	2002-12-26
41	SUPPL	2002-12-26