Details for New Drug Application (NDA): 020622
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NDA 020622 describes COPAXONE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the COPAXONE profile page.
The generic ingredient in COPAXONE is glatiramer acetate. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
The generic ingredient in COPAXONE is glatiramer acetate. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.
Summary for 020622
| Tradename: | COPAXONE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | glatiramer acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020622
Suppliers and Packaging for NDA: 020622
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COPAXONE | glatiramer acetate | FOR SOLUTION;SUBCUTANEOUS | 020622 | NDA | Teva Neuroscience, Inc. | 68546-317 | 68546-317-30 | 30 BLISTER PACK in 1 CARTON (68546-317-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS |
| COPAXONE | glatiramer acetate | FOR SOLUTION;SUBCUTANEOUS | 020622 | NDA | Teva Neuroscience, Inc. | 68546-325 | 68546-325-06 | 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;SUBCUTANEOUS | Strength | 20MG/VIAL | ||||
| Approval Date: | Dec 20, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 20MG/ML | ||||
| Approval Date: | Feb 12, 2002 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 40MG/ML | ||||
| Approval Date: | Jan 28, 2014 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 020622
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-002 | Feb 12, 2002 | ⤷ Get Started Free | ⤷ Get Started Free |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | FOR SOLUTION;SUBCUTANEOUS | 020622-001 | Dec 20, 1996 | ⤷ Get Started Free | ⤷ Get Started Free |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-003 | Jan 28, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| Teva Pharms Usa | COPAXONE | glatiramer acetate | INJECTABLE;SUBCUTANEOUS | 020622-003 | Jan 28, 2014 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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