Oxytetracycline - Generic Drug Details

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What are the generic sources for oxytetracycline and what is the scope of freedom to operate?

Oxytetracycline is the generic ingredient in six branded drugs marketed by Pfizer, Ferrante, Hikma, Impax Labs, Proter, Purepac Pharm, and Casper Pharma Llc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for oxytetracycline.

Sponsor	Phase
University of Oslo	N/A
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

Sponsor

Phase

University of Oslo

N/A

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

Federal University of São Paulo

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TERRAMYCIN	oxytetracycline hydrochloride	INJECTABLE;INJECTION	060586-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	OXYTETRACYCLINE HYDROCHLORIDE	oxytetracycline hydrochloride	CAPSULE;ORAL	060770-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TERRAMYCIN W/ POLYMYXIN	oxytetracycline hydrochloride; polymyxin b sulfate	OINTMENT;OTIC	061841-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TERRAMYCIN	oxytetracycline hydrochloride	CAPSULE;ORAL	050286-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Proter	OXYTETRACYCLINE HYDROCHLORIDE	oxytetracycline hydrochloride	CAPSULE;ORAL	060869-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TERRAMYCIN	oxytetracycline calcium	SYRUP;ORAL	060595-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Casper Pharma Llc	TERRAMYCIN W/ POLYMYXIN B SULFATE	oxytetracycline hydrochloride; polymyxin b sulfate	OINTMENT;OPHTHALMIC	061015-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	6
Applicants:	7
NDAs:	12
Drug Master File Entries:	36
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	5
Patent Applications:	5,948
DailyMed Link:	oxytetracycline at DailyMed