Details for New Drug Application (NDA): 020571
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NDA 020571 describes CAMPTOSAR, 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 CAMPTOSAR profile page.
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.
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 |
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 | ⤷ Subscribe | ⤷ Subscribe |
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Subscribe | ⤷ Subscribe |
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