Application 040674

Type: ANDA
Sponsor: HI-TECH PHARMA CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML;5MG/5ML;6.25MG/5ML	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
A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL			2014-12-23

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 · 43 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
2022-09-29 23:25 UTC	2022-09	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2014-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040674-001	PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL		2014-12-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040674-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040674-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040674-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040674-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040674-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040674-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040674-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040674-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040674-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040674-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040674-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040674-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040674-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040674-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040674-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040674-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040674-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040674-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040674-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040674-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040674-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040674-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040674-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040674-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040674-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040674-001	AA	1	`cb3db0bc1861…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-805	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	Akorn	ANDA	Current
50383-805	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-805	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	Akorn	ANDA	Current
50383-805	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current