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FDA ANDA · ANDA210333

PHENYLEPHRINE HYDROCHLORIDE

Sponsor: MEITHEAL

APPLICATION
ANDA210333
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-27
LATEST ACTION
2020-11-24
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDEPrescription
PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-11-24Labeling · Supplement 2 · standardAP
2018-04-27UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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