Drugs@FDA: FDA-Approved Drugs
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| TESSALON | BENZONATATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 | ACELLA |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 211518 | ASCENT PHARMS INC |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 081297 | BIONPHARMA |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 202765 | CSPC-NBP PHARM |
| BENZONATATE | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | No | AA | 040682 | HERITAGE PHARMS LABS |
| 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 | 040597 | ZYDUS PHARMS USA |
| TESSALON | BENZONATATE | 100MG | CAPSULE;ORAL | Prescription | Yes | AA | 011210 | PFIZER |