Details for New Drug Application (NDA): 075102
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NDA 075102 describes PROPOFOL, which is a drug marketed by Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the PROPOFOL profile page.
The generic ingredient in PROPOFOL is propofol. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the propofol profile page.
The generic ingredient in PROPOFOL is propofol. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the propofol profile page.
Summary for 075102
| Tradename: | PROPOFOL |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | propofol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075102
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 075102
Suppliers and Packaging for NDA: 075102
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPOFOL | propofol | INJECTABLE;INJECTION | 075102 | ANDA | Sagent Pharmaceuticals | 25021-608 | 25021-608-20 | 25 VIAL in 1 CARTON (25021-608-20) / 20 mL in 1 VIAL |
| PROPOFOL | propofol | INJECTABLE;INJECTION | 075102 | ANDA | Sagent Pharmaceuticals | 25021-608 | 25021-608-50 | 20 VIAL in 1 CARTON (25021-608-50) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Jan 4, 1999 | TE: | AB | RLD: | No | ||||
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