Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 207916

Expand all

CETYLEV (ACETYLCYSTEINE)
500MG Marketing Status: Prescription

Active Ingredient: ACETYLCYSTEINE
Proprietary Name: CETYLEV
Dosage Form; Route of Administration: TABLET, EFFERVESCENT; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207916
Product Number: 001
Approval Date: Jan 29, 2016
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CETYLEV (ACETYLCYSTEINE)
2.5GM Marketing Status: Prescription

Active Ingredient: ACETYLCYSTEINE
Proprietary Name: CETYLEV
Dosage Form; Route of Administration: TABLET, EFFERVESCENT; ORAL
Strength: 2.5GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207916
Product Number: 002
Approval Date: Jan 29, 2016
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English