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#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Glycopyrrolate | GLYCOPYRROLATE | Piramal Critical Care Inc | 83d70378-011b-4ce3-e053-2991aa0a22be | 2026-06-23 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Cardinal Health 107, LLC | 65688bed-0d70-4b51-8301-1948b1deade1 | 2026-06-02 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | REMEDYREPACK INC. | 220cd5f5-3d71-4fdb-9943-7468799c179f | 2026-06-02 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Golden State Medical Supply, Inc. | ec15e70c-8473-469a-9f07-ea668783fa07 | 2026-05-27 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Meitheal Pharmaceuticals Inc. | 02541cfd-b209-49b9-a73f-13ef18dce06d | 2026-05-20 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Par Health USA, LLC | ff65c5d3-7ba9-4315-a884-199151eb45a5 | 2026-05-14 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | 098c7654-a352-47ee-bf23-6a81f8601266 | 2026-05-05 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Atlantic Biologicals Corp. | 50b493d7-8e3b-e459-e063-6394a90addbc | 2026-04-30 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Gland Pharma Limited | d670bd26-8a44-44be-90e1-107d4c380233 | 2026-04-28 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| glycopyrrolate | GLYCOPYRROLATE | Amneal Pharmaceuticals LLC | 741355f5-b695-41bb-a065-4abc687312b2 | 2026-04-28 | Warnings, Adverse reactions | glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Sagent Pharmaceuticals | 55930f87-8964-43b1-b790-c1e6dd2602d2 | 2026-04-20 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Bryant Ranch Prepack | 21c7d201-c0b8-4f16-be4a-681d0b22791e | 2026-04-03 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Sandoz Inc | cb1ae370-ec4f-4114-9860-8f736f72b545 | 2026-04-01 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | REMEDYREPACK INC. | a338ef22-c243-4075-b02d-bcd5b590104a | 2026-03-26 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | REMEDYREPACK INC. | fafea739-87d0-4421-833f-eb066791504c | 2026-03-26 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Lifestar Pharma LLC | 0f4a4b94-71e0-49ed-8f1e-c760e4dd3137 | 2026-03-25 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Major Pharmaceuticals | 6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a | 2026-03-19 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |
| glycopyrrolate | GLYCOPYRROLATE | Bionpharma Inc. | 512d3f1e-c35c-87c2-e063-6394a90a8de0 | 2026-03-05 | Warnings, Adverse reactions | glycopyrrolate GLYCOPYRROLATE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | NCS HealthCare of KY, LLC dba Vangard Labs | 5ed930b7-a36e-4bf8-b1d1-dad238d3dd18 | 2026-02-25 | Warnings, Adverse reactions | GLYCOPYRROLATE GLYCOPYRROLATE |
| Glycopyrrolate | GLYCOPYRROLATE | Bryant Ranch Prepack | 10ea264f-e157-4e13-9d79-b4228daf359d | 2026-02-17 | Warnings, Adverse reactions | Glycopyrrolate GLYCOPYRROLATE |