Application 079090
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLONIDINE | CLONIDINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | No | No |
| 002 | CLONIDINE | CLONIDINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.2MG/24HR | No | No |
| 003 | CLONIDINE | CLONIDINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.3MG/24HR | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-453 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-453 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-453 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-453 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-453 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-454 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-454 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-454 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-454 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-454 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-455 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-455 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-455 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-455 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 51862-455 | Clonidine | CLONIDINE | Mayne Pharma Inc. | ANDA | Current |
| 65038-040 | Clonidine | CLONIDINE | Corium International, Inc. | ANDA | Current |
| 65038-041 | Clonidine | CLONIDINE | Corium International, Inc. | ANDA | Current |
| 65038-042 | Clonidine | CLONIDINE | Corium International, Inc. | ANDA | Current |