Document ID: FDA-2019-N-5550-0002
Agency: fda
Document Type: Notice
Title: Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
Posted Date: 2020-04-07T04:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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applications (ANDAs) from multiple applicants, withdrawn as of February 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of the ANDAs withdrawn.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requested that approval of these ANDAs not be withdrawn, the approval 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, Martha.Nguyen@fda.hhs.gov.

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]
BILLING CODE 4164-01-P