Details for New Drug Application (NDA): 091591
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NDA 091591 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Macleods Pharms Ltd, Novel Labs Inc, Rising, and Rubicon, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the CEVIMELINE HYDROCHLORIDE profile page.
The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.
The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.
Summary for 091591
| Tradename: | CEVIMELINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | cevimeline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091591
| Mechanism of Action | Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 091591
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 091591 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0334 | 0054-0334-25 | 100 CAPSULE in 1 BOTTLE (0054-0334-25) |
| CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 091591 | ANDA | Bryant Ranch Prepack | 71335-2264 | 71335-2264-1 | 30 CAPSULE in 1 BOTTLE (71335-2264-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jul 8, 2013 | TE: | AB | RLD: | No | ||||
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