Application 017027
- Type
- NDA
- Sponsor
- 3M
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/0.5ML | No | No |
| 002 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/0.5ML | No | No |
| 003 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/0.5ML | No | No |
| 004 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 20,000 UNITS/0.5ML | No | No |
| 005 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 40,000 UNITS/ML | No | No |
| 006 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | No | No |
| 007 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 20,000 UNITS/ML | No | No |
| 008 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/ML | No | No |
| 009 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/ML | No | No |
| 010 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 7,500 UNITS/0.5ML | No | No |
| 011 | LIPO-HEPIN | HEPARIN SODIUM | INJECTABLE;INJECTION | 15,000 UNITS/0.5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017027-001 | LIPO-HEPIN | HEPARIN SODIUM | 1,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-002 | LIPO-HEPIN | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-003 | LIPO-HEPIN | HEPARIN SODIUM | 10,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-004 | LIPO-HEPIN | HEPARIN SODIUM | 20,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-005 | LIPO-HEPIN | HEPARIN SODIUM | 40,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-006 | LIPO-HEPIN | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-007 | LIPO-HEPIN | HEPARIN SODIUM | 20,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-008 | LIPO-HEPIN | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-009 | LIPO-HEPIN | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-010 | LIPO-HEPIN | HEPARIN SODIUM | 7,500 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N017027-011 | LIPO-HEPIN | HEPARIN SODIUM | 15,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N017027-001 | LIPO-HEPIN | 1,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-002 | LIPO-HEPIN | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-003 | LIPO-HEPIN | 10,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-004 | LIPO-HEPIN | 20,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-005 | LIPO-HEPIN | 40,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-006 | LIPO-HEPIN | 1,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-007 | LIPO-HEPIN | 20,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-008 | LIPO-HEPIN | 5,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-009 | LIPO-HEPIN | 10,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-010 | LIPO-HEPIN | 7,500 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | N017027-011 | LIPO-HEPIN | 15,000 UNITS/0.5ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 9ea0a519-dc7c-42e3-939e-2a7c80eedd25 | 2026-07-10 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | e0cc5f44-9a67-4274-a48a-d6118e96d391 | 2026-06-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 62cfd1bb-894f-4429-b362-1e40981dccc6 | 2026-06-11 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 9cd7abe6-3923-4007-8491-273ef6e05ad7 | 2026-06-02 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium and Dextrose | HEPARIN SODIUM | Hospira, Inc. | eede8a0c-5ae6-4166-84b3-12081405f08e | 2026-05-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | f67eea4e-80ff-48da-8b04-8addc5cd31d1 | 2026-05-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | 0413f511-6b34-4c15-e48b-3fad08baacbe | 2026-05-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | 32e34077-aff1-4ec7-f9b0-b8e240768fb8 | 2026-05-12 | Warnings, Adverse reactions | HEPARIN SODIUM |
| HEPARIN SODIUM | HEPARIN SODIUM | HF Acquisition Co LLC, DBA HealthFirst | 51197aa6-de34-3a55-e063-6294a90a89c9 | 2026-05-05 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | 2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5 | 2026-04-30 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | c8c4edd2-ee9e-4558-6b8c-b83adc242a0a | 2026-04-29 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Plano Pharmaceuticals Inc. | 4deaa9ac-91aa-d96b-e063-6294a90a47bd | 2026-03-25 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Hospira, Inc. | 6c181d7e-aed2-4975-30ac-d39a94cca7ec | 2026-03-24 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Medical Purchasing Solutions, LLC | 4c118b39-cb4e-31a9-e063-6394a90a41b0 | 2026-03-02 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | REMEDYREPACK INC. | a5fab0b1-c472-489c-ba87-2f8e53356173 | 2026-01-16 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Medical Purchasing Solutions, LLC | 463e0624-b8c3-386b-e063-6294a90afd28 | 2025-12-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | d55b4a63-0c04-4874-b74f-9e9b9e8b008c | 2025-11-28 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Fresenius Kabi USA, LLC | ed937dd2-8fab-4875-a1e8-627b71ccb7fb | 2025-11-27 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceticals | ef309d83-7262-4874-8580-f4ca254f963a | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |
| Heparin Sodium | HEPARIN SODIUM | Sagent Pharmaceuticals | 6d5eae7d-a5f6-411c-b589-3e5f7eecc875 | 2025-11-18 | Warnings, Adverse reactions | HEPARIN SODIUM |