Application 207179
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SEVELAMER CARBONATE | SEVELAMER CARBONATE | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8239 | Sevelamer Carbonate | Sevelamer Carbonate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 16714-814 | Sevelamer Carbonate | Sevelamer Carbonate | NorthStar Rx LLC | ANDA | Current |
| 17856-0921 | Sevelamer Carbonate | Sevelamer Carbonate | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0921 | Sevelamer Carbonate | Sevelamer Carbonate | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0921 | Sevelamer Carbonate | Sevelamer Carbonate | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 55154-8188 | Sevelamer Carbonate | Sevelamer Carbonate | Cardinal Health | ANDA | Current |
| 55154-8188 | Sevelamer Carbonate | Sevelamer Carbonate | Cardinal Health 107, LLC | ANDA | Current |
| 60687-328 | Sevelamer Carbonate | Sevelamer Carbonate | American Health Packaging | ANDA | Current |
| 60687-328 | Sevelamer Carbonate | Sevelamer Carbonate | American Health Packaging | ANDA | Current |
| 60687-328 | Sevelamer Carbonate | Sevelamer Carbonate | American Health Packaging | ANDA | Current |
| 60687-328 | Sevelamer Carbonate | Sevelamer Carbonate | American Health Packaging | ANDA | Current |
| 60687-328 | Sevelamer Carbonate | Sevelamer Carbonate | American Health Packaging | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-921 | Sevelamer Carbonate | Sevelamer Carbonate | Aurobindo Pharma Limited | ANDA | Current |
| 70518-0773 | Sevelamer Carbonate | Sevelamer Carbonate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0773 | Sevelamer Carbonate | Sevelamer Carbonate | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49259 | ORIG | 2017-08-07 |