Application 210997
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 0.2MG/ML (0.2MG/ML) | No | No |
| 002 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 0.4MG/2ML (0.2MG/ML) | No | No |
| 003 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 1MG/5ML (0.2MG/ML) | No | No |
| 004 | GLYRX-PF | GLYCOPYRROLATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 0.6MG/3ML (0.2MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210997-001 | GLYRX-PF | GLYCOPYRROLATE | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2018-07-11 | |
| N210997-002 | GLYRX-PF | GLYCOPYRROLATE | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | |
| N210997-003 | GLYRX-PF | GLYCOPYRROLATE | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | |
| N210997-004 | GLYRX-PF | GLYCOPYRROLATE | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-12-14 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2018-07-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GLYRX-PF | GLYCOPYRROLATE | Exela Pharma Sciences, LLC | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 2025-07-23 | Warnings, Adverse reactions | 210997 NDA210997 51754-6001 51754-6015 51754-6000 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51754-6000 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6000 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6000 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6001 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6001 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6001 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6015 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |
| 51754-6015 | GLYRX-PF | glycopyrrolate | Exela Pharma Sciences, LLC | NDA | Current |