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Details for New Drug Application (NDA): 207916

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NDA 207916 describes CETYLEV, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CETYLEV profile page.

The generic ingredient in CETYLEV is acetylcysteine. There are three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for NDA: 207916

Tradename:
CETYLEV
Applicant:
Arbor Pharms Llc
Ingredient:
acetylcysteine
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 207916

Suppliers and Packaging for NDA: 207916

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL 207916 NDA Arbor Pharmaceuticals 24338-700 24338-700-10 10 BLISTER PACK in 1 CARTON (24338-700-10) > 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-700-02)
CETYLEV
acetylcysteine
TABLET, EFFERVESCENT;ORAL 207916 NDA Arbor Pharmaceuticals 24338-725 24338-725-10 10 BLISTER PACK in 1 CARTON (24338-725-10) > 2 TABLET, EFFERVESCENT in 1 BLISTER PACK (24338-725-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EFFERVESCENT;ORALStrength500MG
Approval Date:Jan 29, 2016TE:RLD:No
Patent:9,427,421Patent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:8,747,894Patent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EFFERVESCENT;ORALStrength2.5GM
Approval Date:Jan 29, 2016TE:RLD:Yes
Patent:9,427,421Patent Expiration:May 8, 2032Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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