Application 089393
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | INJECTABLE;INJECTION | 0.2MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089393-001 | GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 |
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 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089393-001 | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE / INJECTION | 1988-06-15 | cb3db0bc1861… |
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 | 10ea264f-e157-4e13-9d79-b4228daf359d | 2026-02-17 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Florida Pharmaceutical Products, LLC | 2cda1ed5-10bb-4651-acbf-be44ad709665 | 2026-02-12 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycate | GLYCOPYRROLATE | Intra-Sana Laboratories | 830ba1be-bef3-417c-a915-964cc6005b92 | 2026-01-13 | Warnings, Adverse reactions | GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | eaf38b98-006f-4f4e-bc1c-6fe381f44b36 | 2026-01-07 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | b96c54a1-b8a5-4132-ae6d-725e0e5b91f4 | 2026-01-07 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate Oral Solution | GLYCOPYRROLATE | AJENAT PHARMACEUTICALS LLC | 7049feaf-004a-481f-b129-996b21c3170a | 2025-12-29 | Warnings, Adverse reactions | GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Jvet Pharmaceuticals LLC | 4b335c67-4f8f-47e5-abfc-f8c2c15496d7 | 2025-12-19 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | REMEDYREPACK INC. | 5d7a742e-2bcf-4db4-a07c-f669938e4068 | 2025-12-17 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Aurolife Pharma LLC | 677f8495-a870-45b6-bb65-75b449f040ce | 2025-12-11 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Chartwell RX, LLC | 5773cf63-4006-4d8f-b53b-c84bcfe19e4a | 2025-12-10 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Rising Pharma Holdings, Inc. | 58c4cb1f-59b8-4be9-a222-2264ca077d93 | 2025-12-03 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate Oral Solution | GLYCOPYRROLATE | Granules Pharmaceuticals Inc. | 0f05c5d3-9c41-4dae-88d1-18cbddc69487 | 2025-12-02 | Warnings, Adverse reactions | GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Amneal Pharmaceuticals LLC | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 2025-12-01 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Solco Healthcare US, LLC | 2972f22e-378c-450b-8869-1354a9bd0ffc | 2025-11-30 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Solco Healthcare US, LLC | 3707f06a-6cba-4f5c-86ab-fb95bc2a933c | 2025-11-30 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | ProPharma Distribution | 430635e8-7c9e-77f6-e063-6294a90a4c8a | 2025-11-07 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Henry Schein, Inc. | 83602e34-7a8c-4606-b43e-23ab909b6c1a | 2025-11-05 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Henry Schein, Inc. | 74d51ba3-0ca0-4a04-aa87-1c243f885bd8 | 2025-11-05 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Henry Schein, Inc. | 4ecb3435-58e5-46cb-b8c2-85b5fd955f83 | 2025-11-03 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Accord Healthcare, Inc., | 871797f0-697a-4a29-a37b-d06219e8f266 | 2025-10-17 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |