Application 084214

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084214-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL			1982-07-07

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084214-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1982-07-07	`f41ea6bd6efb…`

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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	84899861-8fed-536d-e053-2991aa0a42b2	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36	2024-09-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	07914b6e-c40f-44be-a1db-8724c70f99b6	2024-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ea490539-007b-47b1-bef9-22de02ae7c64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	a4b3da5b-1129-43c2-bf22-3a29c3fae116	2024-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8749824b-6d66-430d-e053-2995a90a2db8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	4bf3912c-8339-401e-9711-dad6acf15f11	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	481866da-a712-48a5-853f-8e84aacaab6d	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	365138a6-28d8-4881-a3e9-02c80aaf83e8	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	da246971-20b8-b46e-8366-9700d3604cf1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	2024-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	b6f6698f-f23c-452a-9b38-bbb96ab88ae4	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	1d02d52b-84bb-4e81-b352-125029eb39f6	2024-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b54439a3-1d01-4c5f-8508-731790ae215b	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	5f079815-f48b-8b21-2130-7f791d967c9a	2023-11-30	Boxed warning, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	636bb9bc-0cc5-4d6a-85be-6471acf01ffc	2023-11-30	Boxed warning, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c0c0d4f0-8396-485b-a585-71df01491f6f	2023-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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