FDA Orange Book

Generic for Calcimar

Calcimar contains calcitonin salmon. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Calcimar is calcitonin salmon. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Calcimar products the Orange Book lists.

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Calcimar products in the Orange Book

Calcimar products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection200 IU/MLDiscontinuedNone8AP
injectable, injection400 IU/VIALDiscontinuedNone0None

NDA 017769, 017497, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic calcitonin salmon

Approved generic versions of Calcimar
CompanyANDATE codeApprovedStrengths
CUSTOPHARM INC212416AP (A-rated, therapeutically equivalent)May 14, 2021200 IU/ML
PH HEALTH LTD209358AP (A-rated, therapeutically equivalent)November 10, 2021200 IU/ML
DR REDDYS LABORATORIES LTD215715AP (A-rated, therapeutically equivalent)April 11, 2024200 IU/ML
CIPLA LTD213766AP (A-rated, therapeutically equivalent)September 20, 2024200 IU/ML
FRESENIUS KABI USA LLC212675AP (A-rated, therapeutically equivalent)December 5, 2024200 IU/ML
SAGENT PHARMACEUTICALS219196AP (A-rated, therapeutically equivalent)July 9, 2025200 IU/ML
AMNEAL EU LTD216294AP (A-rated, therapeutically equivalent)September 26, 2025200 IU/ML
ZYDUS PHARMACEUTICALS USA INC215864AP (A-rated, therapeutically equivalent)March 4, 2026200 IU/ML

Questions

Is there a generic for Calcimar?

Yes. The generic name for Calcimar is calcitonin salmon. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Calcimar products the Orange Book lists.

What is the generic name for Calcimar?

The active ingredient in Calcimar is calcitonin salmon, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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