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HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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SYRUP;ORAL	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02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HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1984-04-02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 2 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
2019-12-13 00:20 UTC	2019-12	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	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PHENERGAN VC W/ CODEINE	10MG/5ML;5MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008306-004	PHENERGAN W/ CODEINE	10MG/5ML;6.25MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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 efficacy reasons	SYRUP / ORAL	RLD	1984-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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