Details for New Drug Application (NDA): 205742
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NDA 205742 describes GLYCEROL PHENYLBUTYRATE, which is a drug marketed by Aurobindo Pharma, Esjay Pharma, Lupin, MSN, Navinta Llc, Ph Health, and Teva Pharms Inc, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the GLYCEROL PHENYLBUTYRATE profile page.
The generic ingredient in GLYCEROL PHENYLBUTYRATE is glycerol phenylbutyrate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.
The generic ingredient in GLYCEROL PHENYLBUTYRATE is glycerol phenylbutyrate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.
Summary for 205742
| Tradename: | GLYCEROL PHENYLBUTYRATE |
| Applicant: | Ph Health |
| Ingredient: | glycerol phenylbutyrate |
| Patents: | 0 |
Pharmacology for NDA: 205742
| Mechanism of Action | Ammonium Ion Binding Activity |
Medical Subject Heading (MeSH) Categories for 205742
Suppliers and Packaging for NDA: 205742
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLYCEROL PHENYLBUTYRATE | glycerol phenylbutyrate | LIQUID;ORAL | 205742 | ANDA | Camber Pharmaceuticals, Inc. | 31722-605 | 31722-605-31 | 1 BOTTLE in 1 CARTON (31722-605-31) / 25 mL in 1 BOTTLE |
| GLYCEROL PHENYLBUTYRATE | glycerol phenylbutyrate | LIQUID;ORAL | 205742 | ANDA | Camber Pharmaceuticals, Inc. | 31722-605 | 31722-605-32 | 4 BOTTLE in 1 CARTON (31722-605-32) / 25 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;ORAL | Strength | 1.1GM/ML | ||||
| Approval Date: | Dec 2, 2021 | TE: | AA | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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