PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE — FDA application ANDA200963
Listed sponsor: AMNEAL PHARMS · AMRX company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | SYRUP | ORAL | 10MG/5ML;5MG/5ML;6.25MG/5ML | Prescription | AA | No |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
No Orange Book patent or exclusivity listings joined to this application.
Compound cross-links
- CODEINE PHOSPHATE · UNII GSL05Y1MN6 · lmmol compound DKSZLDSPXIWGFO-BLOJGBSASA-N · CHEMBL6067642
- PHENYLEPHRINE HYDROCHLORIDE · UNII 04JA59TNSJ · lmmol compound OCYSGIYOVXAGKQ-FVGYRXGTSA-N · CHEMBL1200339
- PROMETHAZINE HYDROCHLORIDE · UNII R61ZEH7I1I · lmmol compound XXPDBLUZJRXNNZ-UHFFFAOYSA-N · CHEMBL1200750
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.