Details for New Drug Application (NDA): 208232
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NDA 208232 describes MYCAPSSA, which is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are fourteen patents protecting this drug. Additional details are available on the MYCAPSSA profile page.
The generic ingredient in MYCAPSSA is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
The generic ingredient in MYCAPSSA is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 208232
| Tradename: | MYCAPSSA |
| Applicant: | Chiesi |
| Ingredient: | octreotide acetate |
| Patents: | 14 |
Pharmacology for NDA: 208232
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208232
Suppliers and Packaging for NDA: 208232
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCAPSSA | octreotide acetate | CAPSULE, DELAYED RELEASE;ORAL | 208232 | NDA | Chiesi USA, Inc. | 10122-550 | 10122-550-28 | 4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK |
| MYCAPSSA | octreotide acetate | CAPSULE, DELAYED RELEASE;ORAL | 208232 | NDA | Amryt Pharmaceuticals Designated Activity Company | 69880-120 | 69880-120-28 | 4 BLISTER PACK in 1 DOSE PACK (69880-120-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jun 26, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 26, 2027 | ||||||||
| Regulatory Exclusivity Use: | LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE | ||||||||
| Patent: | 10,238,709 | Patent Expiration: | Feb 3, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE | ||||||||
| Patent: | 10,695,397 | Patent Expiration: | Feb 3, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE | ||||||||
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