Application 080873

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
002	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No
003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No

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
A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982
A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982
A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080873-002	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080873-003	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080873-001	DIPHENHYDRAMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`

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 16 · 310 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer Distribution Inc	f1e83e43-011c-4470-bd55-fb2818a9fc84	2026-07-30	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Sportpharm LLC	e5af2dd2-cc91-46c7-bdb9-97a7cdddcb69	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	879a7804-f3d4-4a3d-bc92-b473499d6c95	2026-07-17	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
ADWE dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	ea3a51af-3025-497f-8cd7-e99391b0d06f	2026-07-17	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	d38f47ea-7fda-170b-e053-2995a90adc82	2026-07-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	f808ee14-fccf-4abe-b53a-a40b0b3bba03	2026-07-04	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Select Consumer Group	55d10292-e673-9896-e063-6294a90a5674	2026-07-04	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	31755678-825c-b84a-e063-6294a90a5a83	2026-06-27	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	319e84fd-4033-f5eb-e063-6394a90aa2f3	2026-06-27	Warnings	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Goodmeds Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	37533188-8c91-428b-a796-c5afd9e4959f	2026-05-27	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	50df93bf-fe72-48f6-a02e-ea9a313d47c2	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	51bb483f-3fe6-8a94-e063-6394a90acf7d	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	bfeae100-e2d1-4607-be3b-2d9b15cd4f7f	2026-05-07	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Allergy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	047102c4-3d03-4b2d-961d-0ac75980147b	2026-05-06	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	d32d074a-f1b6-4a9a-8e10-e19f0e67c61b	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Diphenhydramine Hydrochloride generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Savings Distributors LLC	8d59d121-62a8-c43b-e053-2a95a90a5847	2026-05-01	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0203d919-dc1f-cca0-e063-6394a90aa1aa	2026-04-27	Warnings	Name fallback brand name: DIPHENHYDRAMINE HYDROCHLORIDE generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Tecnu Calagel	DIPHENHYDRAMINE HYDROCHLORIDE	Tec Laboratories Inc.	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	2026-04-20	Warnings	Name fallback generic name: DIPHENHYDRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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