Application 087056
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | TABLET;ORAL | 4MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-1536 | Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 23155-703 | cyproheptadine hydrochloride | cyproheptadine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 53808-0829 | Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1030 | Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18512 | SUPPL | 2013-12-30 |