Home Applications 008306 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HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 005 PHENERGAN VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 1984-04-02 N008306-005 PHENERGAN VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE;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HYDROCHLORIDE 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 1984-04-02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 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 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PHENERGAN W/ CODEINE 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL RLD 1984-04-02 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N008306-005 PHENERGAN VC W/ CODEINE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 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 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 e64feba35796…2022-09-29 23:25 UTC 2022-09 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 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 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 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 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 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 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 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 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 a50c72e98297…
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