APPLICATION
ANDA208905
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-31
LATEST ACTION
2020-07-22
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2020-07-22Labeling · Supplement 3 · standardAP
2020-07-22Labeling · Supplement 2 · standardAP
2019-01-31UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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