Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040749
Company: THEPHARMANETWORK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040749s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

BENZONATATE

CAPSULE;ORAL; 200MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040682 ALEMBIC LABS
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 091310 APOTEX INC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 211518 ASCENT PHARMS INC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 081297 BIONPHARMA INC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 202765 CSPC-NBP PHARM
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040851 MIKART
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 206948 PURACAP PHARM LLC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 210562 QINGDAO BAHEAL PHARM
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 091133 STRIDES PHARMA
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040749 THEPHARMANETWORK LLC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040597 ZYDUS PHARMS USA

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