Details for New Drug Application (NDA): 061147

NDA 061147 describes SUMYCIN, which is a drug marketed by Apothecon, Par Pharm, and Strides Pharma, and is included in three NDAs. It is available from one supplier. Additional details are available on the SUMYCIN profile page.

The generic ingredient in SUMYCIN is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.

Summary for 061147

Tradename:	SUMYCIN
Applicant:	Strides Pharma
Ingredient:	tetracycline hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 061147

Suppliers and Packaging for NDA: 061147

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147	ANDA	Pharmaka Generics Inc.	82644-087	82644-087-60	60 TABLET, FILM COATED in 1 BOTTLE (82644-087-60)
SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147	ANDA	Pharmaka Generics Inc.	82644-870	82644-870-60	60 TABLET, FILM COATED in 1 BOTTLE (82644-870-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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