Details for New Drug Application (NDA): 020571
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The generic ingredient in CAMPTOSAR is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for 020571
Tradename: | CAMPTOSAR |
Applicant: | Pfizer Inc |
Ingredient: | irinotecan hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020571
Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 020571
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571 | NDA | Pharmacia & Upjohn Company LLC | 0009-0082 | 0009-0082-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02) / 15 mL in 1 VIAL, SINGLE-DOSE |
CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571 | NDA | Pharmacia & Upjohn Company LLC | 0009-7529 | 0009-7529-03 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-7529-03) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/2ML (20MG/ML) | ||||
Approval Date: | Jun 14, 1996 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/5ML (20MG/ML) | ||||
Approval Date: | Jun 14, 1996 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/15ML (20MG/ML) | ||||
Approval Date: | Aug 5, 2010 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 020571
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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