Details for New Drug Application (NDA): 050278

NDA 050278 describes ACHROMYCIN V, which is a drug marketed by Avet and Lederle and is included in two NDAs. It is available from one supplier. Additional details are available on the ACHROMYCIN V profile page.

The generic ingredient in ACHROMYCIN V 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 050278

Tradename:	ACHROMYCIN V
Applicant:	Avet
Ingredient:	tetracycline hydrochloride
Patents:	0

Pharmacology for NDA: 050278

Suppliers and Packaging for NDA: 050278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACHROMYCIN V	tetracycline hydrochloride	CAPSULE;ORAL	050278	NDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-017	23155-017-01	100 CAPSULE in 1 BOTTLE (23155-017-01)
ACHROMYCIN V	tetracycline hydrochloride	CAPSULE;ORAL	050278	NDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-018	23155-018-01	100 CAPSULE in 1 BOTTLE (23155-018-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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