Drugs@FDA: FDA-Approved Drugs
Company: ORGANON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIPROLENE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/27/1983 | 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 |
---|---|---|---|---|---|
05/01/2019 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018741s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf | |
03/28/2018 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018741s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf | |
08/13/2014 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf | |
08/28/2006 | SUPPL-28 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s028LTR.pdf | |
11/10/1998 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/15/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/31/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/15/1998 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/30/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/07/2005 | SUPPL-16 | Labeling |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018741s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s016ltr.pdf | |
11/08/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/24/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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11/30/1988 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/29/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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09/12/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/20/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/23/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/22/1985 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/16/1984 | SUPPL-3 | Labeling |
Label is not available on this site. |
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12/15/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/29/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/01/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018741s040lbl.pdf | |
03/28/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018741s038lbl.pdf | |
08/13/2014 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf | |
08/28/2006 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf | |
10/07/2005 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf | |
10/07/2005 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf |
DIPROLENE
OINTMENT, AUGMENTED;TOPICAL; EQ 0.05% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | No | AB | 074304 | ACTAVIS MID ATLANTIC |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | No | AB | 218289 | AUROBINDO PHARMA LTD |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | No | AB | 075373 | FOUGERA PHARMS |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | No | AB | 209106 | LUPIN LTD |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | No | AB | 076753 | TARO |
DIPROLENE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | Yes | AB | 018741 | ORGANON |