Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202675
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG | TABLET;ORAL | Prescription | AA | No | No |
GLYCOPYRROLATE | GLYCOPYRROLATE | 2MG | TABLET;ORAL | Prescription | AA | No | 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 |
---|---|---|---|---|---|---|---|
10/30/2018 | ORIG-2 | Approval |
Label is not available on this site. |
||||
04/15/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
GLYCOPYRROLATE
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 |
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 202675 | AUROBINDO PHARMA |
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 | INDOCO |
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 |
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 |
GLYCOPYRROLATE | GLYCOPYRROLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 202675 | AUROBINDO PHARMA |
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 | INDOCO |
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 |