Application 090575

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	15MG/5ML;6.25MG/5ML	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
A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2011-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090575-001	AA

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	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		2011-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090575-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2011-02-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090575-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090575-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090575-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090575-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090575-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090575-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090575-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090575-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090575-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090575-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090575-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090575-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090575-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090575-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090575-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090575-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090575-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090575-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090575-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090575-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090575-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090575-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090575-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090575-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090575-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090575-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090575-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090575-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090575-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090575-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090575-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090575-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090575-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090575-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090575-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090575-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090575-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090575-001	AA	1	`a50c72e98297…`

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
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Amneal Pharmaceuticals LLC	6081c216-0bed-40f0-8732-f999647003d5	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090575 application number: ANDA090575 ndc (product): 65162-680

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-680	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-680	Promethazine Hydrochloride and Dextomethorphan Hydrobromide	Promethazine Hydrochloride and Dextomethorphan Hydrobromide	Amneal Pharmaceuticals	ANDA	Current
65162-680	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-680	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Amneal Pharmaceuticals LLC	ANDA	Current