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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 |
Generic Entry Opportunity Date for 020287
Generic Entry Date for 020287*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
INJECTABLE;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 020287
Medical Subject Heading (MeSH) Categories for 020287
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 | |||||
| Regulatory Exclusivity Expiration: | May 16, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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 | |||||
| Regulatory Exclusivity Expiration: | May 16, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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 | |||||
| Regulatory Exclusivity Expiration: | May 16, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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 | Start Trial | Start Trial |
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-004 | Jan 30, 1998 | Start Trial | Start Trial |
| Pfizer Inc | FRAGMIN | dalteparin sodium | INJECTABLE;SUBCUTANEOUS | 020287-003 | Mar 18, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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