Application 212696
- Type
- ANDA
- Sponsor
- QUAGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | TABLET;ORAL | 1MG | No | No |
| 002 | GLYCOPYRROLATE | GLYCOPYRROLATE | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212696-001 | GLYCOPYRROLATE | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | |
| A212696-002 | GLYCOPYRROLATE | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212696-001 | AA |
| A212696-002 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | 301d65b070ca… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212696-001 | GLYCOPYRROLATE | 1MG | TABLET / ORAL | AA | 2024-07-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212696-002 | GLYCOPYRROLATE | 2MG | TABLET / ORAL | AA | 2024-07-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A212696-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212696-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212696-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212696-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212696-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212696-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212696-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212696-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212696-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212696-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212696-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212696-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212696-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212696-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212696-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212696-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212696-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212696-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212696-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212696-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212696-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212696-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212696-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212696-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212696-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212696-002 | AA | 1 | 301d65b070ca… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212696-001 | AA | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212696-002 | AA | 1 | 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 |
|---|---|---|---|---|---|---|
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | eaf38b98-006f-4f4e-bc1c-6fe381f44b36 | 2026-01-07 | Warnings, Adverse reactions | 212696 ANDA212696 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | b96c54a1-b8a5-4132-ae6d-725e0e5b91f4 | 2026-01-07 | Warnings, Adverse reactions | 212696 ANDA212696 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | REMEDYREPACK INC. | 5d7a742e-2bcf-4db4-a07c-f669938e4068 | 2025-12-17 | Warnings, Adverse reactions | 212696 ANDA212696 |
| GLYCOPYRROLATE | GLYCOPYRROLATE | QUAGEN PHARMACEUTICALS LLC | a456eaea-4cd6-4344-8fc6-6f6a3ce0f2c6 | 2025-06-14 | Warnings, Adverse reactions | 212696 ANDA212696 |