Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081297
Company: BIONPHARMA 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 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
01/29/1993 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2011 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/30/2007 SUPPL-16 Labeling

Label is not available on this site.

08/29/2002 SUPPL-14 Labeling

Label is not available on this site.

08/29/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/29/2002 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/29/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

12/13/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/30/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/07/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/20/1993 SUPPL-6 Labeling

Label is not available on this site.

05/03/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/24/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/24/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/24/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/23/1993 SUPPL-1 Manufacturing (CMC)

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 040682 ALEMBIC LABS
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-NBP PHARM
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 040851 MIKART
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 206948 PURACAP PHARM LLC
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 210562 QINGDAO BAHEAL PHARM
BENZONATATE BENZONATATE 100MG CAPSULE;ORAL Prescription No AA 091133 STRIDES PHARMA
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; 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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