Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
BENTYL PRESERVATIVE FREE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/13/1952 | 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 |
---|---|---|---|---|---|
01/11/2013 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf | |
08/01/2011 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf | |
02/02/2007 | SUPPL-31 | 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 | |
08/12/2002 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08-370slr030ltr.pdf |
06/23/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/17/1999 | SUPPL-28 | Labeling |
Label is not available on this site. |
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09/06/1996 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
12/23/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
03/18/1991 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/25/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
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01/04/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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02/18/1988 | 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. |
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10/15/1984 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/15/1984 | SUPPL-17 | Labeling |
Label is not available on this site. |
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08/04/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/11/2013 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf | |
08/01/2011 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf | |
02/02/2007 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf |