NDA 11210, held by Pfizer. Benzonatate.
As of Nov 13, 2026, NDA 11210 (Tessalon), held by Pfizer, was first approved by FDA on Feb 10, 1958, with 23 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 1958 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Tessalon100MG · capsule;oral | Benzonatate | RxReference drug |
| Tessalon200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Benzonatate | DiscontinuedReference drug |
| Jan 20, 2011 | Supplement 53Labeling | Approved | |
| Jul 23, 2002 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Nov 1, 2000 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 30, 2000 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1999 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1999 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1993 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1992 | Supplement 31Labeling | Approved | None posted |
| Oct 8, 1986 | Supplement 30Labeling | Approved | None posted |
| Nov 29, 1985 | Supplement 29Labeling | Approved | None posted |
| Nov 29, 1985 | Supplement 25Labeling | Approved | None posted |
| Nov 5, 1985 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1985 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1981 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1980 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1979 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1979 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1978 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1978 | Supplement 18Labeling | Approved | None posted |
| Sep 29, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1975 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1974 | Supplement 11 | Approved | None posted |
| Apr 12, 1972 | Supplement 2Labeling | Approved | None posted |
| Feb 10, 1958 | Original applicationNew molecular entity · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
