Details for New Drug Application (NDA): 020287
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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 |
Ingredient: | dalteparin sodium |
Patents: | 0 |
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 | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-001 | Dec 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-004 | Jan 30, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-003 | Mar 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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