Hydroxocobalamin
Hydroxocobalamin: 1 brand, 5 generics; first approved Dec 15, 2006; generic available.
Generic available: 5 ANDA applications approved.
Brand (NDA) products
- BTG INTLNDA 02204120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/VIAL (5GM/KIT) INJECTABLE INJECTION Rx - 2.5GM/VIAL (5GM/KIT) INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (5)
- MERCKANDA 080778-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued - - HYDROXOCOBALAMINABRAXIS PHARMANDA 084921-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued - - HYDROXOCOBALAMINRSACTAVISANDA 085998-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx - - HYDROXOCOBALAMINWATSON LABSANDA 085528-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued - - BEL MARANDA 084629-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued -
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.
Approval history
Approvals span 2006–2011 across 6 FDA applications.
Hydroxocobalamin: 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.
Assyro Intelligence
Ask anything about Hydroxocobalamin
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo