Details for New Drug Application (NDA): 213224
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NDA 213224 describes BYNFEZIA PEN, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the BYNFEZIA PEN profile page.
The generic ingredient in BYNFEZIA PEN is octreotide acetate. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
The generic ingredient in BYNFEZIA PEN is octreotide acetate. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 213224
| Tradename: | BYNFEZIA PEN |
| Applicant: | Sun Pharm |
| Ingredient: | octreotide acetate |
| Patents: | 5 |
Pharmacology for NDA: 213224
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 213224
Suppliers and Packaging for NDA: 213224
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BYNFEZIA PEN | octreotide acetate | SOLUTION;SUBCUTANEOUS | 213224 | NDA | Sun Pharmaceutical Industries, Inc. | 62756-452 | 62756-452-36 | 1 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE |
| BYNFEZIA PEN | octreotide acetate | SOLUTION;SUBCUTANEOUS | 213224 | NDA | Sun Pharmaceutical Industries, Inc. | 62756-452 | 62756-452-37 | 2 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | ||||
| Approval Date: | Sep 27, 2024 | TE: | RLD: | Yes | |||||
| Patent: | 10,342,850 | Patent Expiration: | May 15, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,052,196 | Patent Expiration: | Nov 3, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES | ||||||||
| Patent: | 11,052,196 | Patent Expiration: | Nov 3, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS | ||||||||
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