Application 205723

Type: ANDA
Sponsor: MICRO LABS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2018-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205723-001	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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205723-001	DIPHENHYDRAMINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2018-08-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205723-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205723-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205723-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205723-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205723-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205723-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205723-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205723-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205723-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205723-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205723-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205723-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205723-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205723-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205723-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205723-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205723-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205723-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205723-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205723-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205723-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205723-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205723-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205723-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205723-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205723-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205723-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205723-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205723-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205723-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205723-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205723-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205723-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205723-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205723-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205723-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205723-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205723-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205723-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205723-001	AP	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIPHENHYDRAMINE	DIPHENHYDRAMINE HYDROCHLORIDE	Micro Labs Limited	a1110433-498a-48cb-ac79-5732fd4f8fba	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205723 application number: ANDA205723 ndc (product): 42571-337 ndc (product): 42571-169
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	ProPharma Distribution	3842d802-9b18-2c5e-e063-6394a90ae763	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205723 application number: ANDA205723
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Armas Pharmaceuticals Inc.	c1cd6138-ca31-4bb5-ae47-2d80d4d54f9d	2023-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205723 application number: ANDA205723 ndc (product): 72485-101
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	95fbf4c2-c96e-2d41-e053-2995a90a0d54	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205723 application number: ANDA205723 ndc (product): 71872-7180

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-169	DIPHENHYDRAMINE	Diphenhydramine Hydrochloride	Micro Labs Limited	ANDA	Current
42571-169	DIPHENHYDRAMINE	Diphenhydramine Hydrochloride	Micro Labs Limited	ANDA	Current
42571-169	DIPHENHYDRAMINE	Diphenhydramine Hydrochloride	Micro Labs Limited	ANDA	Current
42571-337	DIPHENHYDRAMINE	Diphenhydramine Hydrochloride	Micro Labs Limited	ANDA	Current
42571-337	DIPHENHYDRAMINE	Diphenhydramine Hydrochloride	Micro Labs Limited	ANDA	Current
42571-337	DIPHENHYDRAMINE	Diphenhydramine Hydrochloride	Micro Labs Limited	ANDA	Current
70518-3332	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3332	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71872-7180	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
72485-101	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Armas Pharmaceuticals Inc.	ANDA	Current
72485-101	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Armas Pharmaceuticals Inc.	ANDA	Current
72485-102	Diphenhydramine Hydrochloride	Diphenhydramine Hydrochloride	Armas Pharmaceuticals Inc.	ANDA	Current