Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211518
Company: ASCENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription AA No No
BENZONATATE BENZONATATE 150MG CAPSULE;ORAL Prescription AA No No
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription AA 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
02/22/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

BENZONATATE

CAPSULE;ORAL; 100MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 210562 AIPING PHARM INC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 091310 APOTEX INC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 211518 ASCENT PHARMS INC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 081297 BIONPHARMA INC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 202765 CSPC OUYI
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 040851 MIKART
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 040682 ORIT LABS LLC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 206948 PURACAP PHARM LLC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 091133 STRIDES PHARMA
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 040587 SUN PHARM INDS INC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 040627 THEPHARMANETWORK LLC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 040597 ZYDUS PHARMS USA
TESSALON BENZONATATE 100MG CAPSULE;ORAL Prescription Yes AA 011210 PFIZER

CAPSULE;ORAL; 150MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZONATATE BENZONATATE 150MG CAPSULE;ORAL Prescription No AA 210562 AIPING PHARM INC
BENZONATATE BENZONATATE 150MG CAPSULE;ORAL Prescription No AA 211518 ASCENT PHARMS INC
BENZONATATE BENZONATATE 150MG CAPSULE;ORAL Prescription No AA 040851 MIKART
BENZONATATE BENZONATATE 150MG CAPSULE;ORAL Prescription No AA 201209 THEPHARMANETWORK LLC

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 210562 AIPING PHARM INC
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 OUYI
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040851 MIKART
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040682 ORIT LABS LLC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 206948 PURACAP PHARM LLC
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 091133 STRIDES PHARMA
BENZONATATE BENZONATATE 200MG CAPSULE;ORAL Prescription No AA 040587 SUN PHARM INDS INC
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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