Application 212317
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 90MG | No | No |
| 003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-553 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-554 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-555 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 68462-562 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-562 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-850 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-850 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-851 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-851 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67040 | ORIG | 2021-04-13 |