Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208905
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/31/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS; 10MG/ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 211079 AMNEAL PHARMS CO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210334 CIPLA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210665 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210025 PAR STERILE PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208905 SANDOZ INC
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 203826 WEST WARD PHARM CORP
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204300 AVADEL LEGACY

SOLUTION;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 211078 AMNEAL PHARMS CO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210333 CIPLA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210666 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210025 PAR STERILE PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208905 SANDOZ INC
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204300 AVADEL LEGACY

SOLUTION;INTRAVENOUS; 100MG/10ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 211078 AMNEAL PHARMS CO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210333 CIPLA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210666 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 210025 PAR STERILE PRODUCTS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208905 SANDOZ INC
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204300 AVADEL LEGACY

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English