Details for New Drug Application (NDA): 209294
✉ Email this page to a colleague
NDA 209294 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Ixora Lifescience, Jubilant Cadista, Lupin Ltd, Mankind Pharma, Micro Labs, Pharmobedient, Rk Pharma, Sandoz, Taro, Teva, Tp Anda Holdings, Unique, Watson Labs, and Zydus Pharms, and is included in twenty-one NDAs. It is available from eighteen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 209294
| Tradename: | CLOMIPRAMINE HYDROCHLORIDE |
| Applicant: | Lupin Ltd |
| Ingredient: | clomipramine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209294
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 209294 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-492 | 68180-492-01 | 100 CAPSULE in 1 BOTTLE (68180-492-01) |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 209294 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-493 | 68180-493-01 | 100 CAPSULE in 1 BOTTLE (68180-493-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Nov 21, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Nov 21, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
| Approval Date: | Nov 21, 2018 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
