Details for New Drug Application (NDA): 021301
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NDA 021301 describes LEVOXYL, which is a drug marketed by King Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LEVOXYL profile page.
The generic ingredient in LEVOXYL is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
The generic ingredient in LEVOXYL is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021301
| Tradename: | LEVOXYL |
| Applicant: | King Pharms |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021301
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-850 | 60793-850-01 | 100 TABLET in 1 BOTTLE (60793-850-01) |
| LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-850 | 60793-850-10 | 1000 TABLET in 1 BOTTLE (60793-850-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | May 25, 2001 | TE: | AB1,AB3 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | May 25, 2001 | TE: | AB1,AB3 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | May 25, 2001 | TE: | AB1,AB3 | RLD: | Yes | ||||
Expired US Patents for NDA 021301
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-008 | May 25, 2001 | 7,101,569 | ⤷ Get Started Free |
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-004 | May 25, 2001 | 6,555,581 | ⤷ Get Started Free |
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-006 | May 25, 2001 | 7,067,148 | ⤷ Get Started Free |
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-011 | May 25, 2001 | 7,101,569 | ⤷ Get Started Free |
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-008 | May 25, 2001 | 6,555,581 | ⤷ Get Started Free |
| King Pharms | LEVOXYL | levothyroxine sodium | TABLET;ORAL | 021301-009 | May 25, 2001 | 6,555,581 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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