Application 008306

Type: NDA
Sponsor: ANI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	PHENERGAN W/ CODEINE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	PHENERGAN VC W/ CODEINE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N008306-004	PHENERGAN W/ CODEINE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02
N008306-005	PHENERGAN VC W/ CODEINE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1984-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	RLD	1984-04-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	RLD	1984-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	RLD	1984-04-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008306-005	PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP / ORAL	RLD	1984-04-02	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84703	SUPPL	2026-01-07
84528	SUPPL	2025-12-23
76985	SUPPL	2023-12-19
76911	SUPPL	2023-12-18
76910	SUPPL	2023-12-18
54849	SUPPL	2018-07-06
54788	SUPPL	2018-07-06
54751	SUPPL	2018-07-05
49623	SUPPL	2017-08-30
49601	SUPPL	2017-08-30
46882	SUPPL	2017-01-18
46871	SUPPL	2017-01-13
32959	SUPPL	2013-05-14
146	SUPPL	2013-05-13
10698	SUPPL	2009-01-02
92	SUPPL	2008-11-28
40651	SUPPL	2007-07-06