FDA Orange Book · active-ingredient family
Cyanocobalamin
Cyanocobalamin: 9 brands, 36 generics; first approved Nov 10, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 36 ANDA applications approved.
Brands (NDA)
9
Generics (ANDA)
36
Listed patents
0
Presentations
60
Brand (NDA) products
Originator applications
- NASCOBALRLDENDO OPERATIONSNDA 0216422005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Discontinued — - RUBRAMIN PCRLDBRISTOL MYERS SQUIBBNDA 006799—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — - PH HEALTHNDA 0221022007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MCG/SPRAY SPRAY, METERED NASAL Discontinued — - ENDO OPERATIONSNDA 0197221996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/INH GEL, METERED NASAL Discontinued — - PHARMACIA AND UPJOHNNDA 006798—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINWARNER CHILCOTTNDA 007085—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - MERCKNDA 006668—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - BEL MARNDA 010791—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML INJECTABLE INJECTION Discontinued — 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — 0.03MG/ML INJECTABLE INJECTION Discontinued — 0.12MG/ML INJECTABLE INJECTION Discontinued — - BAYER HLTHCARENDA 007012—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (36)
Abbreviated applications
- CYANOCOBALAMINASPIROANDA 2198202026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINMEITHEALANDA 2143162024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINMANKIND PHARMAANDA 2178392024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINLUPINANDA 2106292023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - CYANOCOBALAMINSAGENT PHARMS INCANDA 2151072022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINSOLA PHARMSANDA 2154172022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINZYDUS PHARMSANDA 2146552022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINXIROMEDANDA 2150462021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINSANDOZANDA 2129152021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINEUGIA PHARMAANDA 2138742020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINGLANDANDA 2143902020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINRSPADAGIS ISRAELANDA 2124582020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/SPRAY SPRAY, METERED NASAL Rx AB - CYANOCOBALAMINSOMERSET THERAPS LLCANDA 2094292018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINVITRUVIAS THERAPANDA 2092552018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINPHARMOBEDIENTANDA 2048292017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINSOMERSET THERAPS LLCANDA 2065032015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINMYLAN INSTITUTIONALANDA 0404512003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINSOLOPAKANDA 0875511984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINEPIC PHARMA LLCANDA 0879691983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - LILLYANDA 080855—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — - WATSON LABSANDA 083013—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — - WATSON LABSANDA 083064—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINABRAXIS PHARMANDA 080510—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — 0.03MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINRLDRSAM REGENTANDA 080737—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINDELL LABSANDA 080689—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG/ML INJECTABLE INJECTION Discontinued — 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINDR REDDYSANDA 080573—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 0.1MG/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 080557—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINLUITPOLDANDA 080668—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINLYPHOMEDANDA 083075—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINSANOFI AVENTIS USANDA 080564—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINWATSON LABSANDA 083120—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINWEST-WARD PHARMS INTANDA 080515—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CYANOCOBALAMINWYETH AYERSTANDA 080554—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — - ACCORD HLTHCAREANDA 083022—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - SAVAGE LABSANDA 080570—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CYANOCOBALAMINWEST WARDANDA 084264—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
43 yr 7 mo ago
Most recent approval
3 mo ago
Approvals span 1983–2026 across 45 FDA applications.
Brand (NDA) 920%
Generic (ANDA) 3680%
Cyanocobalamin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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