Assyro AI

FDA Orange Book · active-ingredient family

Cyanocobalamin

Cyanocobalamin is approved as 9 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NASCOBAL · NDA 021642

9

Brand (NDA)

35

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · gel, metered, injectable, spray, metered, tablet

ProductApplicantApplicationTEApproved
NASCOBALRLDENDO OPERATIONSNDA 021642—Jan 31, 2005
RUBRAMIN PCRLD×3BRISTOL MYERS SQUIBBNDA 006799—Approved Prior to Jan 1, 1982
CALOMISTPH HEALTHNDA 022102—Jul 27, 2007
NASCOBALENDO OPERATIONSNDA 019722—Nov 05, 1996
BERUBIGENPHARMACIA AND UPJOHNNDA 006798—Approved Prior to Jan 1, 1982
CYANOCOBALAMINWARNER CHILCOTTNDA 007085—Approved Prior to Jan 1, 1982
REDISOLMERCKNDA 006668—Approved Prior to Jan 1, 1982
RUBIVITE×5BEL MARNDA 010791—Approved Prior to Jan 1, 1982
VI-TWELBAYER HLTHCARENDA 007012—Approved Prior to Jan 1, 1982

Generic (ANDA) products (35)

ProductApplicantApplicationTEApproved
CYANOCOBALAMINMEITHEALANDA 214316APNov 15, 2024
CYANOCOBALAMINMANKIND PHARMAANDA 217839APJul 10, 2024
CYANOCOBALAMINLUPINANDA 210629ABJun 30, 2023
CYANOCOBALAMINSAGENT PHARMS INCANDA 215107APNov 15, 2022
CYANOCOBALAMINSOLA PHARMSANDA 215417APApr 15, 2022
CYANOCOBALAMINZYDUS PHARMSANDA 214655APApr 15, 2022
CYANOCOBALAMINXIROMEDANDA 215046—Aug 20, 2021
CYANOCOBALAMINSANDOZANDA 212915APJan 04, 2021
CYANOCOBALAMINEUGIA PHARMAANDA 213874APDec 08, 2020
CYANOCOBALAMINGLANDANDA 214390APSep 24, 2020
CYANOCOBALAMINPADAGIS ISRAELANDA 212458ABSep 09, 2020
CYANOCOBALAMINSOMERSET THERAPS LLCANDA 209429APDec 18, 2018
CYANOCOBALAMINVITRUVIAS THERAPANDA 209255APDec 18, 2018
CYANOCOBALAMINPHARMOBEDIENTANDA 204829APJun 05, 2017
CYANOCOBALAMINSOMERSET THERAPS LLCANDA 206503APDec 11, 2015
CYANOCOBALAMINMYLAN INSTITUTIONALANDA 040451—Sep 23, 2003
CYANOCOBALAMINSOLOPAKANDA 087551—Feb 29, 1984
CYANOCOBALAMINEPIC PHARMA LLCANDA 087969—Nov 10, 1983
BETALIN 12×2LILLYANDA 080855—Approved Prior to Jan 1, 1982
COBAVITEWATSON LABSANDA 083013—Approved Prior to Jan 1, 1982
COBAVITEWATSON LABSANDA 083064—Approved Prior to Jan 1, 1982
CYANOCOBALAMIN×3ABRAXIS PHARMANDA 080510—Approved Prior to Jan 1, 1982
CYANOCOBALAMINRLDAM REGENTANDA 080737APApproved Prior to Jan 1, 1982
CYANOCOBALAMIN×3DELL LABSANDA 080689—Approved Prior to Jan 1, 1982
CYANOCOBALAMIN×2DR REDDYSANDA 080573—Approved Prior to Jan 1, 1982
VIBISONERLD×2FRESENIUS KABI USAANDA 080557APApproved Prior to Jan 1, 1982
CYANOCOBALAMINLUITPOLDANDA 080668—Approved Prior to Jan 1, 1982
CYANOCOBALAMINLYPHOMEDANDA 083075—Approved Prior to Jan 1, 1982
CYANOCOBALAMINSANOFI AVENTIS USANDA 080564—Approved Prior to Jan 1, 1982
CYANOCOBALAMIN×2WATSON LABSANDA 083120—Approved Prior to Jan 1, 1982
CYANOCOBALAMINWEST-WARD PHARMS INTANDA 080515APApproved Prior to Jan 1, 1982
CYANOCOBALAMIN×2WYETH AYERSTANDA 080554—Approved Prior to Jan 1, 1982
DODEXACCORD HLTHCAREANDA 083022—Approved Prior to Jan 1, 1982
RUVITESAVAGE LABSANDA 080570—Approved Prior to Jan 1, 1982
CYANOCOBALAMINWEST WARDANDA 084264—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.

Cyanocobalamin — 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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