Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017558
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROBINUL GLYCOPYRROLATE 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
02/06/1975 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017558_S000_RobinulTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/05/2018 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017558s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017558Orig1s062ltr.pdf
03/18/2014 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

05/26/2005 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017558s053ltr.pdf
11/05/2004 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf
11/05/2004 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf
06/30/2003 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf
06/30/2003 SUPPL-47 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf
11/05/2004 SUPPL-46 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf
11/05/2004 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf
04/26/2001 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/13/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

09/06/1988 SUPPL-41 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/06/1988 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1988 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1986 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1986 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1986 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1983 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1983 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/19/1982 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1981 SUPPL-26 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/24/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1981 SUPPL-24 Labeling

Label is not available on this site.

10/22/1981 SUPPL-23 Labeling

Label is not available on this site.

10/22/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1980 SUPPL-18 Labeling

Label is not available on this site.

04/01/1980 SUPPL-17 Labeling

Label is not available on this site.

04/01/1980 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1980 SUPPL-15 Labeling

Label is not available on this site.

04/01/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1978 SUPPL-10 Labeling

Label is not available on this site.

08/17/1978 SUPPL-9 Labeling

Label is not available on this site.

04/25/1978 SUPPL-8 Labeling

Label is not available on this site.

11/02/1976 SUPPL-4 Labeling

Label is not available on this site.

09/22/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1975 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
07/05/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017558s062lbl.pdf
05/26/2005 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf

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