Details for New Drug Application (NDA): 212218
NDA 212218 describes CLOMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Jubilant Cadista, Leading, Lupin, Mankind Pharma, Micro Labs, Mpp Pharma, Pharmobedient, Sandoz, Taro, Teva, Tp Anda Holdings, Unique, Watson Labs, and Zydus Pharms, and is included in twenty-one NDAs. It is available from sixteen suppliers. Additional details are available on the CLOMIPRAMINE HYDROCHLORIDE profile page.
The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There is one drug master file entry for this compound. Seventeen 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 is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 212218
| Tradename: | CLOMIPRAMINE HYDROCHLORIDE |
| Applicant: | Jubilant Cadista |
| Ingredient: | clomipramine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 212218
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 21, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 21, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
| Approval Date: | Oct 21, 2019 | TE: | AB | RLD: | No | ||||
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