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Application 205241
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No |
| 002 | HALOPERIDOL DECANOATE | HALOPERIDOL DECANOATE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25021-831 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-831 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-831 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-833 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-833 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-833 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-834 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-834 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 25021-834 | haloperidol decanoate | haloperidol decanoate | Sagent Pharmaceuticals | ANDA | Current |
| 68083-137 | Haloperidol Decanoate | Haloperidol Decanoate | Gland Pharma Limited | ANDA | Current |
| 68083-137 | Haloperidol Decanoate | Haloperidol Decanoate | Gland Pharma Limited | ANDA | Current |
| 68083-137 | Haloperidol Decanoate | Haloperidol Decanoate | Gland Pharma Limited | ANDA | Current |
| 68083-138 | Haloperidol Decanoate | Haloperidol Decanoate | Gland Pharma Limited | ANDA | Current |
| 68083-138 | Haloperidol Decanoate | Haloperidol Decanoate | Gland Pharma Limited | ANDA | Current |
| 68083-138 | Haloperidol Decanoate | Haloperidol Decanoate | Gland Pharma Limited | ANDA | Current |
| 70518-1281 | haloperidol decanoate | haloperidol decanoate | REMEDYREPACK INC. | ANDA | Current |