Sublingual Film definition

Sublingual Film means the pharmaceutically acceptable sublingual film formulation using oral film drug delivery technology in respect of the API psilocybin for each of the four following strengths of such API: 1, 3, 5 and 7 mg.
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Examples of Sublingual Film in a sentence

  • Comment 56: Several commentors spoke to the timing and adequacy of source control with respect to construction of any sediment remedies.

  • Efficacy of Buprenorphine/Naloxone Rapidly Dissolving Sublingual Tablets (BNX-RDT) After Switching From BNX Sublingual Film.

  • In the treatment of opioid dependence, VIVITROL competes with methadone, oral naltrexone, and SUBOXONE® (buprenorphine HCl/naloxone HCl dehydrate sublingual tablets), SUBOXONE® (buprenorphine/naloxone) Sublingual Film, and SUBUTEX® (buprenorphine HCl sublingual tablets), each of which is marketed and sold by Reckitt Benckiser Pharmaceuticals, Inc.

  • Exhibit Number Description 9 9.1 Press Release, dated February 6, 2020, announcing that the FDA confirmed a 505(b)(2) pathway for the Company’s candidate product, AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies.

  • IMPORTANT SAFETY INFORMATION IndicationSUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

  • Your REMS must be fully operational before you introduce Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film into interstate commerce.

  • In the treatment of opioid dependence, VIVITROL competes with methadone, oral naltrexone, and SUBOXONE (buprenorphine HCl/naloxone HCl dehydrate sublingual tablets), SUBOXONE (buprenorphine/naloxone) Sublingual Film, and SUBUTEX (buprenorphine HCl sublingual tablets), each of which is marketed and sold by Reckitt Benckiser Pharmaceuticals, Inc.

  • The Resulting Issuer is committed to progressing its psychedelic division over the next 12 month period through the commercialization of key psychedelic delivery mechanisms such as the Sublingual Film and novel molecules that are expected to improve the bioavailability of psilocybin in the body.

  • Visit www.Indivior.com to learn more.www.indivior.com IndicationSUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated fortreatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

  • On November 30, 2015, Teva submitted NDA 208042 for Buprenorphine and Naloxone Sublingual Film 16 mg/4 mg, a sublingual film formulation containing buprenorphine hydrochloride (BUP) and naloxone hydrochloride (NLX) in a fixed 4:1 ratio.

Related to Sublingual Film

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