Application 074910

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	90MG	No	No
003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6060	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6090	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6120	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-924	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-925	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-926	Diltiazem Hydrochloride	diltiazem hydrochloride	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22382	ORIG	2003-07-28

Application 074910

Related Records#

Application Products#

NDC Listings For This Application#

Documents#