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 is one drug master file entry for this compound. Ten 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RX	Dosage:	CAPSULE;ORAL			Strength	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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RX	Dosage:	CAPSULE;ORAL			Strength	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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