Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206677
Company: ATHENEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

PENTOBARBITAL SODIUM

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEMBUTAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 083246 OAK PHARMS
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 206677 ATHENEX
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 203619 CUSTOPHARM INC
PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 206404 SAGENT PHARMS INC

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