# FRAGMIN — FDA application NDA020287

Informational only - not investment advice.

Application NDA020287 · type NDA · FDA status: approved · original approval 1994-12-22

Listed sponsor: PFIZER · [PFE company profile](/company/PFE/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 2,500IU/0.2ML (12,500IU/ML) | Prescription | not listed | Yes |
| 002 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 10,000IU/0.4ML (25,000IU/ML) | Discontinued | not listed | No |
| 003 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 5,000IU/0.2ML (25,000IU/ML) | Prescription | not listed | Yes |
| 004 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 10,000IU/ML (10,000IU/ML) | Prescription | not listed | Yes |
| 005 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 7,500IU/0.3ML (25,000IU/ML) | Prescription | not listed | Yes |
| 006 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 95,000IU/3.8ML (25,000IU/ML) | Prescription | not listed | Yes |
| 007 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 95,000IU/9.5ML (10,000IU/ML) | Discontinued | not listed | No |
| 008 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | INJECTION | 7,500 IU/0.75ML | Discontinued | not listed | No |
| 009 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 12,500IU/0.5ML (25,000IU/ML) | Prescription | not listed | Yes |
| 010 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 15,000IU/0.6ML (25,000IU/ML) | Prescription | not listed | Yes |
| 011 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 18,000IU/0.72ML (25,000IU/ML) | Prescription | not listed | Yes |
| 012 | FRAGMIN | DALTEPARIN SODIUM | INJECTABLE | SUBCUTANEOUS | 10,000IU/4ML (2,500IU/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

No Orange Book patent or exclusivity listings joined to this application.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- DALTEPARIN SODIUM · UNII 12M44VTJ7B · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/PFE/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA020287. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.