Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests for estrogen-androgen fixed- combination drug products under Docket FDA-1998-P-0083 (formerly 76N- 0377) (DESI 7661) have been withdrawn. Therefore, as proposed in the April 14, 2003, notice of opportunity for hearing (NOOH), FDA finds that the products subject to this proceeding have not been shown to be effective for use under the conditions of use prescribed, recommended, or suggested in the labeling. Shipment in interstate commerce of any product identified in this docket (DESI 7661), or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the date of this notice.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-1998-P-0083 (formerly 76N-0377); DESI 7661] AGENCY: Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests for estrogen-androgen fixed-combination drug products under Docket FDA-1998-P-0083 (formerly 76N-0377) (DESI 7661) have been withdrawn. Therefore, as proposed in the April 14, 2003, notice of opportunity for hearing (NOOH), FDA finds that the products subject to this proceeding have not been shown to be effective for use under the conditions of use prescribed, recommended, or suggested in the labeling. Shipment in interstate commerce of any product identified in this docket (DESI 7661), or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the date of this notice. DATES: This notice is effective June 26, 2026. ADDRESSES: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500 between 9 a.m. and 4 p.m., Monda…
Other Federal Register documents from the same docket.
Citation: 91 FR 31462
