Application 020287
- Type
- NDA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 2,500IU/0.2ML (12,500IU/ML) | Yes | No |
| 002 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 10,000IU/0.4ML (25,000IU/ML) | No | No |
| 003 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 5,000IU/0.2ML (25,000IU/ML) | Yes | No |
| 004 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 10,000IU/ML (10,000IU/ML) | Yes | No |
| 005 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 7,500IU/0.3ML (25,000IU/ML) | Yes | No |
| 006 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 95,000IU/3.8ML (25,000IU/ML) | Yes | Yes |
| 007 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 95,000IU/9.5ML (10,000IU/ML) | No | No |
| 008 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;INJECTION | 7,500 IU/0.75ML | No | No |
| 009 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 12,500IU/0.5ML (25,000IU/ML) | Yes | No |
| 010 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 15,000IU/0.6ML (25,000IU/ML) | Yes | No |
| 011 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 18,000IU/0.72ML (25,000IU/ML) | Yes | No |
| 012 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 10,000IU/4ML (2,500IU/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020287-001 | FRAGMIN | DALTEPARIN SODIUM | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1994-12-22 | |
| N020287-002 | FRAGMIN | DALTEPARIN SODIUM | 10,000IU/0.4ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2007-05-01 | ||
| N020287-003 | FRAGMIN | DALTEPARIN SODIUM | 5,000IU/0.2ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1996-03-18 | |
| N020287-004 | FRAGMIN | DALTEPARIN SODIUM | 10,000IU/ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1998-01-30 | |
| N020287-005 | FRAGMIN | DALTEPARIN SODIUM | 7,500IU/0.3ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2002-04-04 | |
| N020287-006 | FRAGMIN | DALTEPARIN SODIUM | 95,000IU/3.8ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD, RS | 2002-04-04 | |
| N020287-007 | FRAGMIN | DALTEPARIN SODIUM | 95,000IU/9.5ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2002-04-04 | ||
| N020287-008 | FRAGMIN | DALTEPARIN SODIUM | 7,500 IU/0.75ML | INJECTABLE / INJECTION | 2002-04-04 | ||
| N020287-009 | FRAGMIN | DALTEPARIN SODIUM | 12,500IU/0.5ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | |
| N020287-010 | FRAGMIN | DALTEPARIN SODIUM | 15,000IU/0.6ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | |
| N020287-011 | FRAGMIN | DALTEPARIN SODIUM | 18,000IU/0.72ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | |
| N020287-012 | FRAGMIN | DALTEPARIN SODIUM | 10,000IU/4ML (2,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2022-03-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020287-001 | FRAGMIN | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1994-12-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-002 | FRAGMIN | 10,000IU/0.4ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2007-05-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020287-003 | FRAGMIN | 5,000IU/0.2ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1996-03-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-004 | FRAGMIN | 10,000IU/ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1998-01-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-005 | FRAGMIN | 7,500IU/0.3ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2002-04-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-006 | FRAGMIN | 95,000IU/3.8ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD, RS | 2002-04-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-007 | FRAGMIN | 95,000IU/9.5ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2002-04-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020287-008 | FRAGMIN | 7,500 IU/0.75ML | INJECTABLE / INJECTION | 2002-04-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020287-009 | FRAGMIN | 12,500IU/0.5ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-010 | FRAGMIN | 15,000IU/0.6ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-011 | FRAGMIN | 18,000IU/0.72ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020287-012 | FRAGMIN | 10,000IU/4ML (2,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2022-03-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-001 | FRAGMIN | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1994-12-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-002 | FRAGMIN | 10,000IU/0.4ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2007-05-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020287-003 | FRAGMIN | 5,000IU/0.2ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1996-03-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-004 | FRAGMIN | 10,000IU/ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1998-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-005 | FRAGMIN | 7,500IU/0.3ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2002-04-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-006 | FRAGMIN | 95,000IU/3.8ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD, RS | 2002-04-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-007 | FRAGMIN | 95,000IU/9.5ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2002-04-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020287-008 | FRAGMIN | 7,500 IU/0.75ML | INJECTABLE / INJECTION | 2002-04-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020287-009 | FRAGMIN | 12,500IU/0.5ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-010 | FRAGMIN | 15,000IU/0.6ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-011 | FRAGMIN | 18,000IU/0.72ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020287-012 | FRAGMIN | 10,000IU/4ML (2,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2022-03-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-001 | FRAGMIN | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1994-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-002 | FRAGMIN | 10,000IU/0.4ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2007-05-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020287-003 | FRAGMIN | 5,000IU/0.2ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1996-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-004 | FRAGMIN | 10,000IU/ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1998-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-005 | FRAGMIN | 7,500IU/0.3ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2002-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-006 | FRAGMIN | 95,000IU/3.8ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD, RS | 2002-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-007 | FRAGMIN | 95,000IU/9.5ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2002-04-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020287-008 | FRAGMIN | 7,500 IU/0.75ML | INJECTABLE / INJECTION | 2002-04-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020287-009 | FRAGMIN | 12,500IU/0.5ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-010 | FRAGMIN | 15,000IU/0.6ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-011 | FRAGMIN | 18,000IU/0.72ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2007-05-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020287-012 | FRAGMIN | 10,000IU/4ML (2,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 2022-03-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020287-001 | FRAGMIN | 2,500IU/0.2ML (12,500IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1994-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020287-002 | FRAGMIN | 10,000IU/0.4ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | 2007-05-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020287-003 | FRAGMIN | 5,000IU/0.2ML (25,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1996-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020287-004 | FRAGMIN | 10,000IU/ML (10,000IU/ML) | INJECTABLE / SUBCUTANEOUS | RLD | 1998-01-30 | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-001 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-002 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-003 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-004 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-005 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-006 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-007 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-008 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-009 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-010 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020287-011 | NPP | 2022-05-16 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-001 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-002 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-003 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-004 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-005 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-006 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-007 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-008 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-009 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-010 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020287-011 | NPP | 2022-05-16 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-001 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-002 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-003 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-004 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-005 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-006 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-007 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-008 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-009 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-010 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020287-011 | NPP | 2022-05-16 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-001 | NPP | 2022-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-002 | NPP | 2022-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-003 | NPP | 2022-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-004 | NPP | 2022-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-005 | NPP | 2022-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-006 | NPP | 2022-05-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020287-007 | NPP | 2022-05-16 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Fragmin | DALTEPARIN SODIUM | Pfizer Laboratories Div Pfizer Inc | 23527b8b-9b28-4e6d-9751-33b143975ac7 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 020287 NDA020287 0069-0196 0069-0195 0069-0206 0069-0220 0069-0223 0069-0232 0069-0217 0069-0228 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0195 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0196 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0206 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0217 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0220 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0223 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0228 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0232 | Fragmin | Dalteparin Sodium | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79934 | SUPPL | 2024-12-02 |
| 80010 | SUPPL | 2024-10-28 |
| 79997 | SUPPL | 2024-10-25 |
| 79909 | SUPPL | 2024-10-16 |
| 65549 | SUPPL | 2020-12-09 |
| 65517 | SUPPL | 2020-12-08 |
| 63787 | SUPPL | 2020-07-02 |
| 63786 | SUPPL | 2020-07-02 |
| 63751 | SUPPL | 2020-06-30 |
| 63750 | SUPPL | 2020-06-30 |
| 58767 | SUPPL | 2019-05-17 |
| 58751 | SUPPL | 2019-05-16 |
| 48406 | SUPPL | 2017-05-17 |
| 48370 | SUPPL | 2017-05-12 |
| 44997 | SUPPL | 2016-08-04 |
| 44987 | SUPPL | 2016-08-04 |
| 34480 | SUPPL | 2015-10-07 |
| 24741 | SUPPL | 2015-10-01 |
| 12420 | SUPPL | 2015-01-30 |
| 24740 | SUPPL | 2015-01-27 |
| 41270 | SUPPL | 2012-03-27 |
| 24739 | SUPPL | 2010-10-26 |
| 34479 | SUPPL | 2010-10-25 |
| 24738 | SUPPL | 2010-01-05 |
| 34478 | SUPPL | 2009-12-30 |
| 20586 | SUPPL | 2008-08-11 |
| 41268 | SUPPL | 2008-08-01 |
| 41267 | SUPPL | 2008-08-01 |
| 41269 | SUPPL | 2008-07-31 |
| 20590 | SUPPL | 2007-07-06 |
| 20589 | SUPPL | 2007-07-06 |
| 34477 | SUPPL | 2007-05-07 |
| 2302 | SUPPL | 2007-05-07 |
| 2301 | SUPPL | 2004-04-29 |
| 34476 | SUPPL | 2003-12-16 |
| 24737 | SUPPL | 2003-12-16 |
| 2300 | SUPPL | 2003-07-06 |
| 2296 | SUPPL | 2003-03-10 |
| 24736 | SUPPL | 2002-11-19 |
| 2299 | SUPPL | 2002-11-01 |
| 24735 | SUPPL | 2002-04-04 |
| 24734 | SUPPL | 2002-04-04 |
| 2298 | SUPPL | 2002-04-04 |
| 34475 | SUPPL | 2000-08-03 |
| 2297 | SUPPL | 2000-08-03 |
| 41266 | SUPPL | 1999-05-25 |
| 34474 | SUPPL | 1999-05-25 |
| 24733 | SUPPL | 1999-05-25 |
| 34473 | SUPPL | 1999-03-30 |
| 20588 | SUPPL | 1999-03-30 |
| 2295 | SUPPL | 1999-03-30 |
| 20587 | SUPPL | 1998-02-04 |
| 62923 | SUPPL | 1900-01-01 |