Application 075401
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 002 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 003 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 240MG | No | No |
| 004 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 005 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 360MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24658-341 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-342 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-343 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-344 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-345 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 62037-696 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-696 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-696 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-697 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-697 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-697 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-698 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-698 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-698 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-699 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-699 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-699 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-700 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-700 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-700 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22468 | ORIG | 2005-07-22 |
| 8648 | ORIG | 2004-06-18 |