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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2018-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-12-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | d06236e962d9… |
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 |
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 |