Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007961
Company: APTALIS PHARMA US
Company: APTALIS PHARMA US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
04/30/1951 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
08/01/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf | |
02/02/2007 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf | |
08/17/1999 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
09/09/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
09/25/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
01/04/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/06/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
06/12/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/13/1985 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
10/15/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/15/1984 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
08/04/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/01/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf | |
02/02/2007 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf |