FRAGMIN — FDA application NDA020287
Listed sponsor: PFIZER · PFE company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
No Orange Book patent or exclusivity listings joined to this application.
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 · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.