MedPath
FDA Approval

Biorphen

September 30, 2022

HUMAN PRESCRIPTION DRUG LABEL

Phenylephrine(10 mg in 1 mL)

Manufacturing Establishments (1)

SINTETICA SA

Dr. Reddy's Laboratories Inc.

480601586

Products (2)

Biorphen

43598-199

NDA212909

NDA (C73594)

INTRAVENOUS

September 30, 2022

Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
NITROGENInactive
Code: N762921K75Class: IACT

Biorphen

43598-172

NDA212909

NDA (C73594)

INTRAVENOUS

September 30, 2022

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
Code: 04JA59TNSJClass: ACTIBQuantity: 0.1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
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