Is there a generic for Tetracycline phosphate complex?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Tetracycline phosphate complex, referencing the brand TETREX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tetracycline phosphate complex?

TETREX (NDA 050212, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tetracycline phosphate complex are approved?

Tetracycline phosphate complex is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Tetracycline phosphate complex

Tetracycline phosphate complex is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TETREX · NDA 050212

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
TETREX×2	BRISTOL	NDA 050212	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TETREX×3	BRISTOL	ANDA 061653	—	Approved Prior to Jan 1, 1982
TETREX×2	BRISTOL	ANDA 061889	—	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.

Tetracycline phosphate complex — frequently asked questions

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

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