Requests that the FDA declare that Naloxone HC1 Nasal Spray, 8 mg/Spray, is suitable for submission as an ANDA and to introduce a new 8 mg/Spray metered spray strength for prescription use
Suitability Petition CDER HYMAN, PHELPS & MCNAMARA, P.C. for prescription use metered spray strength introduce a new 8 mg/Spray Approved Drug Products with Orange Book Therapeutic Equivalence Evaluations Reference Listed Drug (RLD) as an ANDA Abbreviated New Drug Application (ANDA) is suitable for submission 8 mg/Spray declare that Naloxone HCl Nasal Spray OPEN
2021-08-20
FDA-2021-P-0514-0006
04:00:00
https://api.regulations.gov/v4/comments/FDA-2021-P-0514-0006
Anonymous
Anonymous
On behalf of Hikma Pharmaceuticals USA, Inc. (Hikma), the undersigned submits the following comments pursuant to 21 C.F.R.  10.30(d) opposing the above-referenced suitability petition.