Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COGENTIN | BENZTROPINE MESYLATE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| COGENTIN | BENZTROPINE MESYLATE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| COGENTIN | BENZTROPINE MESYLATE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/05/1954 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2009 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/22/2001 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf |
| 04/15/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1996 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/20/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1986 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/13/1984 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/15/1984 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 06/02/1981 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/19/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/01/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1977 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/15/1975 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/01/1974 | SUPPL-10 | Unspecified |
Label is not available on this site. |