Details for New Drug Application (NDA): 018057
✉ Email this page to a colleague
NDA 018057 describes PLATINOL-AQ, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the PLATINOL-AQ profile page.
The generic ingredient in PLATINOL-AQ is cisplatin. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cisplatin profile page.
The generic ingredient in PLATINOL-AQ is cisplatin. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cisplatin profile page.
Summary for 018057
| Tradename: | PLATINOL-AQ |
| Applicant: | Hq Spclt Pharma |
| Ingredient: | cisplatin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018057
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CISPLATIN | cisplatin | INJECTABLE;INJECTION | 018057 | NDA | WG Critical Care, LLC | 44567-509 | 44567-509-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (44567-509-01) / 50 mL in 1 VIAL, MULTI-DOSE |
| CISPLATIN | cisplatin | INJECTABLE;INJECTION | 018057 | NDA | WG Critical Care, LLC | 44567-510 | 44567-510-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (44567-510-01) / 100 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/ML | ||||
| Approval Date: | Jul 18, 1984 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 018057
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hq Spclt Pharma | PLATINOL-AQ | cisplatin | INJECTABLE;INJECTION | 018057-003 | Jul 18, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
| Hq Spclt Pharma | PLATINOL | cisplatin | INJECTABLE;INJECTION | 018057-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Hq Spclt Pharma | CISPLATIN | cisplatin | INJECTABLE;INJECTION | 018057-004 | Nov 8, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Hq Spclt Pharma | CISPLATIN | cisplatin | INJECTABLE;INJECTION | 018057-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Hq Spclt Pharma | CISPLATIN | cisplatin | INJECTABLE;INJECTION | 018057-004 | Nov 8, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
| Hq Spclt Pharma | PLATINOL-AQ | cisplatin | INJECTABLE;INJECTION | 018057-003 | Jul 18, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
