Assyro AI

FDA Orange Book · active-ingredient family

Tolbutamide

Tolbutamide is approved as 2 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ORINASE · NDA 010670

2

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ORINASE×2PHARMACIA AND UPJOHNNDA 010670—Approved Prior to Jan 1, 1982
TOLBUTAMIDESANDOZNDA 012678—Approved Prior to Jan 1, 1982

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
TOLBUTAMIDEWATSON LABSANDA 089110—May 29, 1987
TOLBUTAMIDEWATSON LABSANDA 089111—May 29, 1987
TOLBUTAMIDEPUREPAC PHARMANDA 088950—Jun 17, 1985
TOLBUTAMIDESUPERPHARMANDA 088893—Nov 19, 1984
TOLBUTAMIDEASCOTANDA 087541—Mar 01, 1983
TOLBUTAMIDEVANGARDANDA 087876—Apr 20, 1982
TOLBUTAMIDEALRAANDA 086141—Approved Prior to Jan 1, 1982
TOLBUTAMIDEANI PHARMSANDA 087093—Approved Prior to Jan 1, 1982
TOLBUTAMIDEBARRANDA 087121—Approved Prior to Jan 1, 1982
TOLBUTAMIDECHARTWELL RXANDA 086574—Approved Prior to Jan 1, 1982
TOLBUTAMIDEDAVA PHARMS INCANDA 086926—Approved Prior to Jan 1, 1982
TOLBUTAMIDEPARKE DAVISANDA 086047—Approved Prior to Jan 1, 1982
TOLBUTAMIDEPHARMOBEDIENTANDA 086445—Approved Prior to Jan 1, 1982
TOLBUTAMIDEWATSON LABSANDA 086109—Approved Prior to Jan 1, 1982
TOLBUTAMIDEWATSON LABSANDA 087318—Approved Prior to Jan 1, 1982

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.

Tolbutamide — frequently asked questions

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

Agent CTA Background

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