Details for New Drug Application (NDA): 050810
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NDA 050810 describes AZASITE, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the AZASITE profile page.
The generic ingredient in AZASITE is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
The generic ingredient in AZASITE is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 050810
| Tradename: | AZASITE |
| Applicant: | Thea Pharma |
| Ingredient: | azithromycin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050810
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810 | NDA | Thea Pharma Inc. | 82584-307 | 82584-307-02 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER |
| AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810 | NDA | Thea Pharma Inc. | 82584-307 | 82584-307-03 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Apr 27, 2007 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 050810
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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