Details for New Drug Application (NDA): 091099
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NDA 091099 describes IMIPRAMINE PAMOATE, which is a drug marketed by Hikma, Lupin Ltd, and Rising, and is included in three NDAs. It is available from two suppliers. Additional details are available on the IMIPRAMINE PAMOATE profile page.
The generic ingredient in IMIPRAMINE PAMOATE is imipramine pamoate. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
The generic ingredient in IMIPRAMINE PAMOATE is imipramine pamoate. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
Summary for 091099
| Tradename: | IMIPRAMINE PAMOATE |
| Applicant: | Hikma |
| Ingredient: | imipramine pamoate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091099
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE PAMOATE | imipramine pamoate | CAPSULE;ORAL | 091099 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0273 | 0054-0273-13 | 30 CAPSULE in 1 BOTTLE (0054-0273-13) |
| IMIPRAMINE PAMOATE | imipramine pamoate | CAPSULE;ORAL | 091099 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0274 | 0054-0274-13 | 30 CAPSULE in 1 BOTTLE (0054-0274-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG HYDROCHLORIDE | ||||
| Approval Date: | Apr 16, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG HYDROCHLORIDE | ||||
| Approval Date: | Apr 16, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 125MG HYDROCHLORIDE | ||||
| Approval Date: | Apr 16, 2010 | TE: | AB | RLD: | No | ||||
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