Assyro AI

FDA Orange Book · active-ingredient family

Methyldopa

Methyldopa is approved as 3 brand and 43 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALDOMET · NDA 013400

3

Brand (NDA)

43

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension, tablet

ProductApplicantApplicationTEApproved
ALDOMETRLD×3MERCKNDA 013400—Approved Prior to Jan 1, 1982
METHYLDOPA×2CHARTWELL RXNDA 018934—Jun 29, 1984
ALDOMETMERCKNDA 018389—Approved Prior to Jan 1, 1982

Generic (ANDA) products (43)

ProductApplicantApplicationTEApproved
METHYLDOPASUPERPHARMANDA 070669—Jun 23, 1989
METHYLDOPASUPERPHARMANDA 070670—Jun 23, 1989
METHYLDOPAPLIVAANDA 072126—Jul 07, 1988
METHYLDOPAPLIVAANDA 072127—Jul 07, 1988
METHYLDOPAPLIVAANDA 072128—Jul 07, 1988
METHYLDOPAHALSEYANDA 071751—Mar 28, 1988
METHYLDOPAHALSEYANDA 071752—Mar 28, 1988
METHYLDOPAHALSEYANDA 071753—Mar 28, 1988
METHYLDOPACHARTWELL RXANDA 071700—Mar 02, 1988
METHYLDOPAQUAGENANDA 070535—Jan 02, 1987
METHYLDOPAQUAGENANDA 070536—Jan 02, 1987
METHYLDOPAQUAGENANDA 070537—Jan 02, 1987
METHYLDOPADURAMED PHARMS BARRANDA 071006—Dec 16, 1986
METHYLDOPADURAMED PHARMS BARRANDA 071009—Dec 16, 1986
METHYLDOPATEVAANDA 071105—Dec 05, 1986
METHYLDOPATEVAANDA 071106—Dec 05, 1986
METHYLDOPATEVAANDA 071067—Dec 05, 1986
METHYLDOPASUN PHARM INDUSTRIESANDA 070073—Oct 09, 1986
METHYLDOPASUN PHARM INDUSTRIESANDA 070060—Oct 09, 1986
METHYLDOPASUN PHARM INDUSTRIESANDA 070074—Oct 09, 1986
METHYLDOPAWATSON LABSANDA 070703—Jun 06, 1986
METHYLDOPAWATSON LABSANDA 070625—Jun 06, 1986
METHYLDOPAROXANEANDA 070192—Apr 25, 1986
METHYLDOPAROXANEANDA 070193—Apr 25, 1986
METHYLDOPAROXANEANDA 070194—Apr 25, 1986
METHYLDOPAPARKE DAVISANDA 070331—Apr 15, 1986
METHYLDOPAPARKE DAVISANDA 070332—Apr 15, 1986
METHYLDOPAPARKE DAVISANDA 070333—Apr 15, 1986
METHYLDOPAWATSON LABSANDA 070245—Feb 25, 1986
METHYLDOPAWATSON LABSANDA 070246—Feb 25, 1986
METHYLDOPAWATSON LABSANDA 070247—Feb 25, 1986
METHYLDOPAHERITAGE PHARMAANDA 070098—Feb 20, 1986
METHYLDOPAHERITAGE PHARMAANDA 070343—Feb 20, 1986
METHYLDOPAPUREPAC PHARMANDA 070749—Feb 07, 1986
METHYLDOPAPUREPAC PHARMANDA 070750—Feb 07, 1986
METHYLDOPAPUREPAC PHARMANDA 070452—Feb 07, 1986
METHYLDOPAACCORD HLTHCAREANDA 070070—Oct 15, 1985
METHYLDOPAACCORD HLTHCAREANDA 070084—Oct 15, 1985
METHYLDOPAACCORD HLTHCAREANDA 070085—Oct 15, 1985
METHYLDOPAWATSON LABSANDA 070260—Jun 24, 1985
METHYLDOPAWATSON LABSANDA 070261—Jun 24, 1985
METHYLDOPAWATSON LABSANDA 070262—Jun 24, 1985
METHYLDOPA×2RISINGANDA 070076—Apr 18, 1985

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Methyldopa — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo