Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 206880
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | No | No |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1000MG/100ML (10MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | No | No |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1500MG/100ML (15MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/25/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVETIRACETAM IN SODIUM CHLORIDE
INJECTABLE;IV (INFUSION); 500MG/100ML (5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 207160 | AUROBINDO PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 206880 | GLAND PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | Yes | AP | 202543 | HQ SPECIALITY PHARMA |
INJECTABLE;IV (INFUSION); 1000MG/100ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1000MG/100ML (10MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 207160 | AUROBINDO PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1000MG/100ML (10MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 206880 | GLAND PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1000MG/100ML (10MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | Yes | AP | 202543 | HQ SPECIALITY PHARMA |
INJECTABLE;IV (INFUSION); 1500MG/100ML (15MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1500MG/100ML (15MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 207160 | AUROBINDO PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1500MG/100ML (15MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | No | AP | 206880 | GLAND PHARMA LTD |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1500MG/100ML (15MG/ML) | INJECTABLE;IV (INFUSION) | Prescription | Yes | AP | 202543 | HQ SPECIALITY PHARMA |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English