FDA Orange Book · active-ingredient family
Calcitonin salmon
Calcitonin salmon: 4 brands, 11 generics; first approved Jul 03, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
11
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- MIACALCINRLDALLIEDNDA 0203131995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/SPRAY SPRAY, METERED NASAL Discontinued — - MIACALCINRLDMYLAN IRELAND LTDNDA 01780819862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100 IU/ML INJECTABLE INJECTION Discontinued — 200 IU/ML INJECTABLE INJECTION Rx AP - CALCIMARRLDSANOFI AVENTIS USNDA 017769—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Discontinued — - SANOFI AVENTIS USNDA 017497—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 IU/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- CALCITONIN-SALMONZYDUS PHARMSANDA 2158642026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONAMNEALANDA 2162942025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONSAGENTANDA 2191962025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONFRESENIUS KABI USAANDA 2126752024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONCIPLAANDA 2137662024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONDR REDDYSANDA 2157152024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONPH HEALTHANDA 2093582021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONCUSTOPHARM INCANDA 2124162021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION Rx AP - CALCITONIN-SALMONPH HEALTHANDA 0769792009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/SPRAY SPRAY, METERED NASAL Rx AB - CALCITONIN-SALMONRSAPOTEX INCANDA 0763962008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/SPRAY SPRAY, METERED NASAL Rx AB - CALCITONIN-SALMONIGI LABS INCANDA 0736901995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200 IU/ML INJECTABLE INJECTION 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
40 yr 8 mo ago
Most recent approval
5 mo ago
Approvals span 1986–2026 across 15 FDA applications.
Brand (NDA) 427%
Generic (ANDA) 1173%
Calcitonin salmon: 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.
