Details for New Drug Application (NDA): 206408
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NDA 206408 describes PROPOFOL, which is a drug marketed by Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Hikma, Hospira, Innopharma, Sagent Pharms Inc, Teva Parenteral, and Watson Labs Inc, and is included in ten 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 206408
| Tradename: | PROPOFOL |
| Applicant: | Avet Lifesciences |
| Ingredient: | propofol |
| Patents: | 0 |
Pharmacology for NDA: 206408
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 206408
Suppliers and Packaging for NDA: 206408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPOFOL | propofol | INJECTABLE;INJECTION | 206408 | ANDA | NorthStar Rx LLC | 16714-528 | 16714-528-10 | 10 VIAL in 1 CARTON (16714-528-10) / 20 mL in 1 VIAL (16714-528-01) |
| PROPOFOL | propofol | INJECTABLE;INJECTION | 206408 | ANDA | NorthStar Rx LLC | 16714-528 | 16714-528-20 | 20 VIAL in 1 CARTON (16714-528-20) / 20 mL in 1 VIAL (16714-528-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Oct 12, 2021 | TE: | AB | RLD: | No | ||||
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