Methyldopate Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2013-10-24)
Oldest Current Product
1995-09-30
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\METHYLDOPATE
FDAOB
INJECTION\INJECTION\METHYLDOPATE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\METHYLDOPATE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\METHYLDOPA ANHYDROUS

product(s) by strength(s)

methyldopate 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005178905ANDAAmerican Regent, Inc.1995-09-30METHYLDOPATE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA071279f5f25053-a9f3-48b9-a412-078f5ee942fd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070291METHYLDOPATE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1986-07-01ANDA070291_001
2ANDA070652METHYLDOPATE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-06-03ANDA070652_001
3ANDA070691METHYLDOPATE HYDROCHLORIDETrueHOSPIRA INC1987-06-19ANDA070691_001
4ANDA070698METHYLDOPATE HYDROCHLORIDETrueHOSPIRA INC1987-06-15ANDA070698_001
5ANDA070699METHYLDOPATE HYDROCHLORIDETrueHOSPIRA INC1987-06-15ANDA070699_001
6ANDA070841METHYLDOPATE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-01-02ANDA070841_001
7ANDA070849METHYLDOPATE HYDROCHLORIDETrueHOSPIRA INC1987-06-19ANDA070849_001
8ANDA071279METHYLDOPATE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC1987-10-02ANDA071279_001
9ANDA071812METHYLDOPATE HYDROCHLORIDETrueMARSAM PHARMACEUTICALS LLC1987-12-22ANDA071812_001
10ANDA072974METHYLDOPATE HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC1991-11-22ANDA072974_001
11NDA013401ALDOMETTrueMERCK AND CO INCNDA013401_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070291_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1986-07-01METHYLDOPATE HYDROCHLORIDE
2ANDA070652_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1986-06-03METHYLDOPATE HYDROCHLORIDE
3ANDA070691_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1987-06-19METHYLDOPATE HYDROCHLORIDE
4ANDA070698_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1987-06-15METHYLDOPATE HYDROCHLORIDE
5ANDA070699_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1987-06-15METHYLDOPATE HYDROCHLORIDE
6ANDA070841_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1987-01-02METHYLDOPATE HYDROCHLORIDE
7ANDA070849_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1987-06-19METHYLDOPATE HYDROCHLORIDE
8ANDA071279_001RXMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAP1987-10-02METHYLDOPATE HYDROCHLORIDE
9ANDA071812_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1987-12-22METHYLDOPATE HYDROCHLORIDE
10ANDA072974_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1991-11-22METHYLDOPATE HYDROCHLORIDE
11NDA013401_001discontinuedMETHYLDOPATE HYDROCHLORIDE (50MG/ML)INJECTIONFalseALDOMET

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f5f25053-a9f3-48b9-a412-078f5ee942fd (view SPL)Methyldopate HCl Injection, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-10-246005178905

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII