Details for New Drug Application (NDA): 205960
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NDA 205960 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
Summary for 205960
| Tradename: | ASENAPINE MALEATE |
| Applicant: | Breckenridge |
| Ingredient: | asenapine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205960
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 205960 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-358 | 51991-358-11 | 10 BLISTER PACK in 1 BOX (51991-358-11) / 10 TABLET in 1 BLISTER PACK (51991-358-99) |
| ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 205960 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-358 | 51991-358-60 | 6 BLISTER PACK in 1 BOX (51991-358-60) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2.5MG 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 | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Mar 8, 2021 | TE: | AB | RLD: | No | ||||
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