Application 091526

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

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

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

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
A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2013-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091526-001	AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091526-001	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION	AP	2013-03-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091526-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091526-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091526-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091526-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091526-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091526-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091526-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091526-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091526-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091526-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091526-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091526-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091526-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091526-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091526-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091526-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091526-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091526-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091526-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091526-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091526-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091526-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091526-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091526-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091526-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091526-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091526-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091526-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091526-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091526-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091526-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091526-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091526-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091526-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091526-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091526-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091526-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091526-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091526-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091526-001	AP	1	`3a93d1ddd44b…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	6d1aa0e2-036d-4382-a458-fc0300dba7cb	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091526 application number: ANDA091526 ndc (product): 76045-102

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76045-102	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-102	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-102	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39617	ORIG	2013-03-26