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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207916

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CETYLEV (ACETYLCYSTEINE)
500MG
Marketing Status: Discontinued
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:  Discontinued
Patent and Exclusivity Information
CETYLEV (ACETYLCYSTEINE)
2.5GM
Marketing Status: Discontinued
Active Ingredient: ACETYLCYSTEINE
Proprietary Name: CETYLEV
Dosage Form; Route of Administration: TABLET, EFFERVESCENT; ORAL
Strength: 2.5GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207916
Product Number: 002
Approval Date: Jan 29, 2016
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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