Application 208477
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LORATADINE | LORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0363-4020 | CHILDRENS LORATADINE ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0363-4020 | CHILDRENS LORATADINE ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0363-4020 | CHILDRENS LORATADINE ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0363-9937 | Loratadine ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0363-9937 | Loratadine ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0363-9937 | Loratadine ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0363-9937 | Loratadine ODT | Loratadine | WALGREEN CO. | ANDA | Current |
| 0536-1367 | Loratadine ODT | Loratadine | Rugby Laboratories | ANDA | Current |
| 46122-539 | Loratadine ODT | Loratadine | Amerisource Bergen | ANDA | Current |
| 46122-539 | Loratadine ODT | Loratadine | Amerisource Bergen | ANDA | Current |
| 46122-539 | Loratadine ODT | Loratadine | Amerisource Bergen | ANDA | Current |
| 46122-539 | Loratadine ODT | Loratadine | Amerisource Bergen | ANDA | Current |
| 46122-539 | Loratadine ODT | Loratadine | Amerisource Bergen | ANDA | Current |
| 49035-806 | Loratadine ODT | Loratadine | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-806 | Loratadine ODT | Loratadine | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-806 | Loratadine ODT | Loratadine | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-806 | Loratadine ODT | Loratadine | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-806 | Loratadine ODT | Loratadine | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-806 | Loratadine ODT | Loratadine | Wal-Mart Stores, Inc. | ANDA | Current |
| 53943-035 | Loratadine ODT | Loratadine | DISCOUNT DRUG MART | ANDA | Current |
| 53943-035 | Loratadine ODT | Loratadine | DISCOUNT DRUG MART | ANDA | Current |
| 53943-035 | Loratadine ODT | Loratadine | DISCOUNT DRUG MART | ANDA | Current |
| 58602-744 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-744 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-744 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-821 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-821 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-821 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-830 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-830 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-830 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 58602-881 | Loratadine ODT | Loratadine | Aurohealth LLC | ANDA | Current |
| 60000-950 | Loratadine ODT | Loratadine | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-950 | Loratadine ODT | Loratadine | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-950 | Loratadine ODT | Loratadine | Ahold U.S.A., Inc, | ANDA | Current |
| 68016-088 | Loratadine ODT | Loratadine | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-088 | Loratadine ODT | Loratadine | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-088 | Loratadine ODT | Loratadine | Chain Drug Consortium, LLC | ANDA | Current |
| 69842-085 | Loratadine ODT | Loratadine | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-085 | Loratadine ODT | Loratadine | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-085 | Loratadine ODT | Loratadine | CVS Pharmacy, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72836 | SUPPL | 2022-12-09 |