Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204438
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
08/09/2021 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204438Orig1s000ltr.pdf |
GLYCOPYRROLATE
SOLUTION;ORAL; 1MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CUVPOSA | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 022571 | MERZ PHARMS |
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 213698 | ANNORA PHARMA |
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 216368 | CHARTWELL RX |
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 204438 | ENDO OPERATIONS |
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 214735 | GRANULES |
GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 212467 | SUVEN PHARMS |