Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 011210
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESSALON BENZONATATE 100MG CAPSULE;ORAL Prescription AA Yes No
TESSALON BENZONATATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
02/10/1958 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2011 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf
07/23/2002 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/01/2000 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/2000 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/25/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/01/1993 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/04/1992 SUPPL-31 Labeling

Label is not available on this site.

10/08/1986 SUPPL-30 Labeling

Label is not available on this site.

11/29/1985 SUPPL-29 Labeling

Label is not available on this site.

11/05/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1985 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1985 SUPPL-25 Labeling

Label is not available on this site.

07/15/1981 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/03/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1979 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/06/1979 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/29/1978 SUPPL-18 Labeling

Label is not available on this site.

09/29/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1974 SUPPL-11

Label is not available on this site.

04/12/1972 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/20/2011 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf

TESSALON

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 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 210562 QINGDAO BAHEAL PHARM
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English