Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
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 21 CFR Parts 520, 522, and 526 [Docket No. FDA-2019-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective March 30, 2020 FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug ( printed page 18126) Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: File No. Product name 21 CFR section 055-036 PRINCILLIN (ampicillin trihydrate) Capsules 520.90c. 055-050 PRINCILLIN (ampicillin trihydrate) Soluble Powder 520.90e. 055-056 PRINCILLIN (ampicillin trihydrate) Bolus 520.90f. 055-061 PRINCILLIN “125” For Oral Suspension 520.90d. 055-068 BOVICLOX (cloxacillin benzathine) 526.464b. 065-013 Dihydrostreptomycin (dihydrostreptomycin sulfate) 522.650. 065-493 JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension 522.1696a. 065-500 TANDEM PEN (penicillin G procaine) 522.1696…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor's Address
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Citation: 85 FR 18125
