Is there a generic for Bacampicillin hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Bacampicillin hydrochloride. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Bacampicillin hydrochloride?

SPECTROBID (NDA 050556, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Bacampicillin hydrochloride are approved?

Bacampicillin hydrochloride is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Bacampicillin hydrochloride

Bacampicillin hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SPECTROBID · NDA 050556

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for suspension, tablet

Product	Applicant	Application	TE	Approved
SPECTROBID	PFIZER	NDA 050556	—	Mar 23, 1982
SPECTROBID×2	PFIZER	NDA 050520	—	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.

Bacampicillin hydrochloride — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo