Application 040903
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42291-345 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE | ANDA | Current |
| 42291-345 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-346 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE | ANDA | Current |
| 42291-346 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-347 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-347 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE | ANDA | Current |
| 50090-3148 | Imipramine Hydrochloride | Imipramine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3148 | Imipramine Hydrochloride | Imipramine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LL | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LL | ANDA | Current |
| 64125-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Excellium Pharmaceutical, Inc | ANDA | Current |
| 64125-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Excellium Pharmaceutical, Inc | ANDA | Current |
| 64125-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Excellium Pharmaceutical, Inc | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 70518-0006 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0006 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0127 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 38902 | ORIG | 2013-10-04 |