Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction

---
identifier: "/us/fr/2023-20742"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2023-20742"
section_name: "Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction"
positive_law: false
currency: "2023-09-25"
last_updated: "2023-09-25"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-20742"
document_type: "notice"
publication_date: "2023-09-25"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "88 FR 65691"
fr_volume: 88
docket_ids:
  - "Docket No. FDA-2023-N-2079"
fr_action: "Notice; correction."
---


#  Hospira, Inc., et al.; Withdrawal of Approval of Eight 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 entitled “Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications” that appeared in the *Federal Register* of June 2, 2023. The document announced the withdrawal of approval (as of July 3, 2023) of eight abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of ANDA 077029, Calcipotriene Solution, 0.005% after receiving a withdrawal request from Tolmar, Inc., 701 Centre Ave., Fort Collins, CO 80526. Before FDA withdrew the approval of this ANDA, Tolmar, Inc. informed FDA that it did not want the approval of the ANDA withdrawn. Because Tolmar, Inc. timely requested that approval of ANDA 077029 not be withdrawn, the approval is still in effect. This document corrects that error.

**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 Friday, June 2, 2023 (88 FR 36320), in FR Doc. 2023-11744, the following correction is made:

On page 36321, in the table, the entry for ANDA 077029 is removed.

Dated: September 20, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.