[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Page 24734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09898]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0021]
Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated
New Drug Applications for Prescription Pain Medications Containing More
Than 325 Milligrams of Acetaminophen; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of March 27, 2014 (79 FR 17163).
The document withdrew approval of 108 abbreviated new drug applications
(ANDAs) for prescription pain medications containing more than 325
milligrams (mg) of acetaminophen per dosage unit from multiple
applicants, effective March 27, 2014. The document failed to withdraw
approval of ANDAs 040825, 040822, and 040824, held by Ranbaxy
Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East, Princeton, NJ
08540, and ANDA 040182, held by Pharmaceutical Associates, Inc., 201
Delaware St., Greenville, SC 29605. The holders of these applications
have voluntarily requested that approval of these applications be
withdrawn and have waived their opportunity for a hearing. FDA confirms
the withdrawal of approval of ANDAs 040825, 040824, 040822, and 040182.
FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.
SUPPLEMENTARY INFORMATION: In FR Doc. 2014-06801, appearing on page
17163, in the Federal Register of Thursday, March 27, 2014, the
following correction is made:
On page 17166, in table 1, the following entries are added in
alphabetical order by Applicant:
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Application No. Drug product(s) Applicant or holder
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ANDA 040182......... Acetaminophen and Pharmaceutical
Hydrocodone Bitartrate Associates, Inc., 201
Oral Solution, 7.5 mg/ Delaware St.,
500 mg/15 milliters Greenville, SC 29605.
(mL), available in 473
mL, 118 mL, 15 mL, and
10 mL.
ANDA 040825......... Acetaminophen and Ranbaxy Laboratories
Hydrocodone Bitartrate Inc., 600 College Rd.
Tablets, 500 mg/5 mg. East, Princeton, NJ
08540.
ANDA 040822......... Acetaminophen and Do.
Hydrocodone Bitartrate
Tablets, 750 mg/7.5 mg.
ANDA 040824......... Acetaminophen and Ranbaxy Inc., 600
Hydrocodone Bitartrate College Rd. East,
Tablets, 500 mg/10 mg. Princeton, NJ 08540.
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Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09898 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P