Details for New Drug Application (NDA): 017849
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The generic ingredient in BRETHINE is terbutaline sulfate. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 017849
Tradename: | BRETHINE |
Applicant: | Ani Pharms |
Ingredient: | terbutaline sulfate |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017849
Suppliers and Packaging for NDA: 017849
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-721 | 62559-721-01 | 100 TABLET in 1 BOTTLE (62559-721-01) |
BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-722 | 62559-722-01 | 100 TABLET in 1 BOTTLE (62559-722-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 017849
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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