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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210333
Company: MEITHEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP1 No No
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP1 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
04/27/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210333Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/24/2020 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP1

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 AP1 213237 ACCORD HLTHCARE
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 211078 AMNEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 218110 ASPIRO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 213318 CAPLIN
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210025 ENDO OPERATIONS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210697 EUGIA PHARMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210666 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 211920 GLAND PHARMA LTD
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 218412 HAINAN POLY
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 217069 MANKIND PHARMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210333 MEITHEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 211081 PROVEPHARM SAS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 209967 SAGENT PHARMS INC
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 208905 SANDOZ
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP1 204300 EXELA PHARMA

SOLUTION;INTRAVENOUS; 100MG/10ML (10MG/ML)
TE Code = AP1

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 AP1 213237 ACCORD HLTHCARE
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 211078 AMNEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 218110 ASPIRO
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 213318 CAPLIN
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210025 ENDO OPERATIONS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210697 EUGIA PHARMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210666 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 211920 GLAND PHARMA LTD
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 218412 HAINAN POLY
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 217069 MANKIND PHARMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 210333 MEITHEAL
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 211081 PROVEPHARM SAS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 209967 SAGENT PHARMS INC
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP1 208905 SANDOZ
VAZCULEP PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP1 204300 EXELA PHARMA
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