Details for New Drug Application (NDA): 020482
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The generic ingredient in PRECOSE is acarbose. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acarbose profile page.
Summary for 020482
Tradename: | PRECOSE |
Applicant: | Bayer Hlthcare |
Ingredient: | acarbose |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020482
Suppliers and Packaging for NDA: 020482
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRECOSE | acarbose | TABLET;ORAL | 020482 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-951 | 43353-951-09 | 9000 TABLET in 1 BOTTLE (43353-951-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 6, 1995 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 6, 1995 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 29, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 020482
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | PRECOSE | acarbose | TABLET;ORAL | 020482-004 | May 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | PRECOSE | acarbose | TABLET;ORAL | 020482-002 | Sep 6, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | PRECOSE | acarbose | TABLET;ORAL | 020482-001 | Sep 6, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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