Drugs@FDA: FDA-Approved Drugs
Company: SS PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PARLODEL | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| PARLODEL | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/12/2021 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017962s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017962Orig1s083ltr.pdf | |
| 12/13/2019 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017962s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017962Orig1s081ltr.pdf | |
| 11/26/2014 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2016 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2014 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2012 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf | |
| 01/05/2012 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017962s065,s068ltr.pdf | |
| 11/09/2005 | SUPPL-64 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm | |
| 11/09/2005 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017962s063,064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm | |
| 02/21/2002 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/2001 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1999 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1999 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1998 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1998 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1999 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 04/02/1998 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 07/03/1996 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1995 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/1995 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 06/09/1995 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1994 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/13/1995 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1994 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/29/1992 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/29/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/09/1992 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1990 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1990 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1990 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/1989 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1990 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 07/01/1987 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/28/1987 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/21/1987 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1984 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/28/1985 | SUPPL-18 | Efficacy |
Label is not available on this site. |
||
| 11/30/1983 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1984 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/06/1981 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/04/1981 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1981 | SUPPL-6 | Unspecified |
Label is not available on this site. |
||
| 09/23/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/17/1979 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/27/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2021 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017962s083lbl.pdf | |
| 12/13/2019 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017962s081lbl.pdf | |
| 01/05/2012 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf | |
| 01/05/2012 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf | |
| 11/09/2005 | SUPPL-64 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf | |
| 11/09/2005 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf |
PARLODEL
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 077646 | PADAGIS US |
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 074631 | SANDOZ |
| PARLODEL | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 017962 | SS PHARMA |
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077226 | MYLAN |
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078899 | ZYDUS PHARMS USA INC |
| PARLODEL | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017962 | SS PHARMA |