Details for New Drug Application (NDA): 215910
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NDA 215910 describes SEZABY, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SEZABY profile page.
The generic ingredient in SEZABY is phenobarbital sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenobarbital sodium profile page.
The generic ingredient in SEZABY is phenobarbital sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenobarbital sodium profile page.
Summary for 215910
| Tradename: | SEZABY |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | phenobarbital sodium |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215910
Generic Entry Date for 215910*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 215910
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEZABY | phenobarbital sodium | POWDER;INTRAVENOUS | 215910 | NDA | Sun Pharmaceutical Industries, Inc. | 62756-301 | 62756-301-01 | 1 INJECTION in 1 VIAL, SINGLE-DOSE (62756-301-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Nov 17, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 17, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS | ||||||||
| Patent: | 11,857,683 | Patent Expiration: | Apr 7, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING NEONATAL SEIZURES | ||||||||
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