Drugs@FDA: FDA-Approved Drugs
Company: CASPER PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROBINUL | GLYCOPYRROLATE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
ROBINUL FORTE | GLYCOPYRROLATE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/11/1961 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
07/31/2015 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/25/2003 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12827scp049ltr.pdf |
10/18/2002 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/21/2002 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/15/2002 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/15/2002 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/07/1999 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/23/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/13/1990 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/27/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/19/1988 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/15/1988 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/16/1986 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/22/1986 | SUPPL-35 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s035_Robinul Forte Tablets.pdf |
07/16/1985 | SUPPL-34 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/012827s034lbl.pdf | |
11/07/1983 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s032&s033_Robinul & Robinul Forte Tablets.pdf |
11/07/1983 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s032&s033_Robinul & Robinul Forte Tablets.pdf |
01/04/1983 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/03/1982 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/18/1982 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/06/1981 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/05/1981 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/30/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s024&s025_Robinul_Robinul_Forte_Tabs.pdf |
01/30/1981 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s024&s025_Robinul_Robinul_Forte_Tabs.pdf |
06/26/1980 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/07/1980 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
01/07/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/24/1979 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
04/12/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
04/06/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
02/22/1979 | SUPPL-17 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s017_Robinul-Robinul_Forte_Tabs.pdf |
08/23/1978 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
09/27/1977 | SUPPL-15 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s015_Robinul - Robinul_Forte_Tabs.pdf |
07/13/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s014_Robinul_Forte_Tabs.pdf |
12/29/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/09/1976 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/18/1976 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul%20&%20Robinul%20Forte_Tablets.pdf |
02/18/1976 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul%20&%20Robinul%20Forte_Tablets.pdf |
02/18/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/012827_s009_s010_s011_Robinul & Robinul Forte_Tablets.pdf |
12/17/1975 | SUPPL-8 | Unspecified |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/16/1985 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/012827s034lbl.pdf |
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