Details for New Drug Application (NDA): 021212
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NDA 021212 describes CAVERJECT IMPULSE, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the CAVERJECT IMPULSE profile page.
The generic ingredient in CAVERJECT IMPULSE is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
The generic ingredient in CAVERJECT IMPULSE is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.
Summary for 021212
| Tradename: | CAVERJECT IMPULSE |
| Applicant: | Pfizer |
| Ingredient: | alprostadil |
| Patents: | 0 |
Pharmacology for NDA: 021212
| Mechanism of Action | Prostaglandin Receptor Agonists |
| Physiological Effect | Genitourinary Arterial Vasodilation Venous Vasodilation |
Medical Subject Heading (MeSH) Categories for 021212
Suppliers and Packaging for NDA: 021212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212 | NDA | Pharmacia & Upjohn Company LLC | 0009-5181 | 0009-5181-01 | 2 SYRINGE in 1 CARTON (0009-5181-01) / .5 mL in 1 SYRINGE (0009-5181-10) |
| CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212 | NDA | Pharmacia & Upjohn Company LLC | 0009-5182 | 0009-5182-01 | 2 SYRINGE in 1 CARTON (0009-5182-01) / .5 mL in 1 SYRINGE (0009-5182-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.01MG/VIAL | ||||
| Approval Date: | Jun 11, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.02MG/VIAL | ||||
| Approval Date: | Jun 11, 2002 | TE: | RLD: | No | |||||
Expired US Patents for NDA 021212
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-001 | Jun 11, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-002 | Jun 11, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-002 | Jun 11, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-001 | Jun 11, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-002 | Jun 11, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | CAVERJECT IMPULSE | alprostadil | INJECTABLE;INJECTION | 021212-001 | Jun 11, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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