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Details for New Drug Application (NDA): 020287
NDA 020287 describes FRAGMIN, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the FRAGMIN profile page.
The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.
The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.
Summary for 020287
| Tradename: | FRAGMIN |
| Applicant: | Pfizer Inc |
| Ingredient: | dalteparin sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020287
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FRAGMIN | dalteparin sodium | INJECTABLE;INJECTION | 020287 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0195 | 0069-0195-02 | 10 SYRINGE in 1 CARTON (0069-0195-02) > .2 mL in 1 SYRINGE (0069-0195-01) |
| FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0195 | 0069-0195-02 | 10 SYRINGE in 1 CARTON (0069-0195-02) > .2 mL in 1 SYRINGE (0069-0195-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 2,500IU/0.2ML (12,500IU/ML) | ||||
| Approval Date: | Dec 22, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 10,000IU/0.4ML (25,000IU/ML) | ||||
| Approval Date: | May 1, 2007 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 5,000IU/0.2ML (25,000IU/ML) | ||||
| Approval Date: | Mar 18, 1996 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020287
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-001 | Dec 22, 1994 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-003 | Mar 18, 1996 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-004 | Jan 30, 1998 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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