Is there a generic for Calcium gluceptate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Calcium gluceptate, referencing the brand CALCIUM GLUCEPTATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Calcium gluceptate?

CALCIUM GLUCEPTATE (NDA 006470, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Calcium gluceptate are approved?

Calcium gluceptate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Calcium gluceptate

Calcium gluceptate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CALCIUM GLUCEPTATE · NDA 006470

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CALCIUM GLUCEPTATE	LILLY	NDA 006470	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
CALCIUM GLUCEPTATE	ABRAXIS PHARM	ANDA 089373	—	Apr 30, 1987
CALCIUM GLUCEPTATERLD	ABBOTT	ANDA 080001	—	Approved Prior to Jan 1, 1982
CALCIUM GLUCEPTATE	ABBOTT	ANDA 083159	—	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.

Calcium gluceptate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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