Press Release For India Vicodin made by RanbaxyRanbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
Submitted by jmorri2nd on August 20, 2007 - 7:07pm.
PRINCETON, N.J., Aug. 20 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc.
(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),
announced today that RLL has received approval from the U.S. Food and
drugAdministration to manufacture and market Hydrocodone Bitartrate and
Acetaminophen Tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10
mg/325 mg strengths. The Office of Generic Drugs, U.S. Food and
drugAdministration, has determined the Ranbaxy formulations to be bioequivalent
and have the same therapeutic effect as that of the reference listed drugs
as follows: 10 mg/325 mg Norco Tablets of Watson Pharmaceuticals Inc., 5
mg/500 mg Vicodin Tablets, and 7.5 mg/750 mg Vicodin ES Tablets both of
Abbott Laboratories, and 10 mg/500 mg Lortab Tablets of UCB Inc. Total
annual market sales for Hydrocodone Bitartrate and Acetaminophen Tablets
were $390.6 million (IMS - MAT: June 2007).
"Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the
relief of moderate to moderately severe pain, and Ranbaxy is pleased to
receive final FDA approval for multiple strengths of this product. These
approvals further expand our product portfolio of affordable generic
alternatives and will be launched in a November 2007 time period to all
classes of trade," according to Jim Meehan, Vice President of Sales and
Marketing for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a
wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's
largest pharmaceutical company. RPI is engaged in the sale and distribution
of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated,
research based, international pharmaceutical company producing a wide range
of quality, affordable generic medicines, trusted by healthcare
professionals and patients across geographies. Ranbaxy's continued focus on
R&D has resulted in several approvals in developed markets and significant
progress in New
drug Discovery Research. The Company's foray into Novel
drug Delivery Systems has led to proprietary "platform technologies",
resulting in a number of products under development. The Company is serving
its customers in over 125 countries and has an expanding international
portfolio of affiliates, joint ventures and alliances, ground operations in
49 countries and manufacturing operations in 11 countries.
*Vicodin(R) ES Tablets is a registered trademark of Abbott Laboratories
*Norco(R) Tablets is a registered trademark of Watson Pharmaceuticals Inc.
*Lortab(R) Tablets is a registered trademark of UCB Inc.
Ranbaxy Vicodin Imprints and descriptionsHow is Hydrocodone Bitartrate and Acetaminophen Supplied
Hydrocodone Bitartrate and Acetaminophen tablets, USP are available in the following strengths:
5 mg/500 mg White to off-white capsule shaped, uncoated tablets, debossed with RX on the left side of the bisect and 560 on the right side of the bisect and plain on the other side NDC 63304-560-03 Bottles of 10 NDC 63304-560-01 Bottles of 100 NDC 63304-560-05 Bottles of 500 NDC 63304-560-69 Unit-dose pack of 10
7.5 mg/750 mg White to off-white round, uncoated tablets, debossed with RX above the bisect and 496 below the bisect and plain on the other side NDC 63304-496-03 Bottles of 10 NDC 63304-496-01 Bottles of 100 NDC 63304-496-05 Bottles of 500 NDC 63304-496-69 Unit-dose pack of 10
10 mg/325 mg White to off-white round, uncoated tablets, debossed with RX above the bisect and 497 below the bisect and plain on the other side NDC 63304-497-03 Bottles of 10 NDC 63304-497-01 Bottles of 100 NDC 63304-497-05 Bottles of 500 NDC 63304-497-10 Bottles of 1000 NDC 63304-497-69 Unit-dose pack of 10
10 mg/500 mg White to off-white round, uncoated tablets, debossed with RX above the bisect and 498 below the bisect and plain on the other side NDC 63304-498-03 Bottles of 10 NDC 63304-498-01 Bottles of 100 NDC 63304-498-05 Bottles of 500 NDC 63304-498-69 Unit-dose pack of 10
Store at 20 - 25°C (68 - 77°F). [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.
Manufactured for
Ranbaxy Pharmaceuticals Inc.
Jacksonville, FL 32257 USA
By: Ohm Laboratories Inc.
North Brunswick, NJ 08902 USA
April 2008