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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012827
Company: CASPER PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROBINUL GLYCOPYRROLATE 1MG TABLET;ORAL Prescription AA Yes No
ROBINUL FORTE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription AA 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
09/27/2022 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012827s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012827Orig1s059ltr.pdf
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
09/27/2022 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012827s059lbl.pdf
07/16/1985 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/012827s034lbl.pdf

ROBINUL

TABLET;ORAL; 1MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 203657 ALEMBIC LABS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 202675 AUROLIFE PHARMA LLC
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040847 DR REDDYS LABS LTD
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 207201 HERITAGE PHARMS INC
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 091182 KENTON
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 090195 LEADING
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 091413 NATCO
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 090020 OXFORD PHARMS
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040653 PAR PHARM
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040821 RISING
GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET;ORAL Prescription No AA 040844 SUN PHARM INDS LTD
ROBINUL GLYCOPYRROLATE 1MG TABLET;ORAL Prescription Yes AA 012827 CASPER PHARMA LLC

ROBINUL FORTE

TABLET;ORAL; 2MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 203657 ALEMBIC LABS
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 202675 AUROLIFE PHARMA LLC
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040847 DR REDDYS LABS LTD
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 207201 HERITAGE PHARMS INC
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 091182 KENTON
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 090195 LEADING
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 091413 NATCO
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 090020 OXFORD PHARMS
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040653 PAR PHARM
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040821 RISING
GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription No AA 040844 SUN PHARM INDS LTD
ROBINUL FORTE GLYCOPYRROLATE 2MG TABLET;ORAL Prescription Yes AA 012827 CASPER PHARMA LLC
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