Details for New Drug Application (NDA): 216440
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NDA 216440 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Chemistry Hlth, Jubilant Cadista, Lupin Ltd, Mankind Pharma, Micro Labs, Mylan, Rk Pharma, Sandoz, Taro, Teva, Tulex Pharms Inc, Unique, Watson Labs, and Zydus Pharms, and is included in twenty-one NDAs. It is available from twenty-three suppliers. Additional details are available on the CLOMIPRAMINE HYDROCHLORIDE profile page.
The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 216440
| Tradename: | CLOMIPRAMINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | clomipramine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216440
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 216440 | ANDA | Aurobindo Pharma Limited | 59651-381 | 59651-381-01 | 100 CAPSULE in 1 BOTTLE (59651-381-01) |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 216440 | ANDA | Aurobindo Pharma Limited | 59651-381 | 59651-381-30 | 30 CAPSULE in 1 BOTTLE (59651-381-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 20, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 20, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
| Approval Date: | Mar 20, 2023 | TE: | AB | RLD: | No | ||||
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