Details for New Drug Application (NDA): 206107
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NDA 206107 describes ASENAPINE MALEATE, which is a drug marketed by Alembic, Breckenridge, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ASENAPINE MALEATE profile page.
The generic ingredient in ASENAPINE MALEATE is asenapine maleate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
The generic ingredient in ASENAPINE MALEATE is asenapine maleate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
Summary for 206107
| Tradename: | ASENAPINE MALEATE |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | asenapine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206107
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107 | ANDA | Sigmapharm Laboratories, LLC | 42794-016 | 42794-016-08 | 30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08) |
| ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107 | ANDA | Sigmapharm Laboratories, LLC | 42794-016 | 42794-016-10 | 60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No | ||||
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