[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Page 19491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5550]
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23
Abbreviated New Drug Applications; 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 on January 8, 2020. The document
announced the withdrawal of approval of 23 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of February
7, 2020. The document indicated that FDA was withdrawing approval of
the following seven ANDAs after receiving a withdrawal request from
CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave.,
24th Floor, New York, NY 10016: ANDA 073191, Triamterene and
Hydrochlorothiazide Capsules USP, 50 milligrams (mg)/25 mg; ANDA
076075, Econazole Nitrate Cream, 1%; ANDA 076192, Ribavirin Capsules
USP, 200 mg; ANDA 076514, Midodrine Hydrochloride (HCl) Tablets USP,
2.5 mg, 5 mg, and 10 mg; ANDA 086809, Spironolactone Tablets USP, 25
mg; ANDA 090288, Naratriptan Tablets USP, Equivalent to (EQ) 1 mg base
and EQ 2.5 mg base; and ANDA 203384, Epinastine HCl Ophthalmic
Solution, 0.05%. Before FDA withdrew the approval of these ANDAs, CASI
Pharmaceuticals, Inc., informed FDA that it did not want the approval
of the ANDAs withdrawn. Because CASI Pharmaceuticals, Inc., timely
requested that approval of these ANDAs not be withdrawn, the approval
of ANDAs 073191, 076075, 076192, 076514, 086809, 090288, and 203384 is
still in effect.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday,
January 8, 2020 (85 FR 909), in FR Doc. 2020-00076, on page 909, the
following correction is made:
1. On pages 909 and 910, in the table, the entries for ANDAs
073191, 076075, 076192, 076514, 086809, 090288, and 203384 are removed.
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07265 Filed 4-6-20; 8:45 am]
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