Details for New Drug Application (NDA): 020237
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NDA 020237 describes SALAGEN, which is a drug marketed by Concordia and is included in one NDA. It is available from three suppliers. Additional details are available on the SALAGEN profile page.
The generic ingredient in SALAGEN is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
The generic ingredient in SALAGEN is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 020237
| Tradename: | SALAGEN |
| Applicant: | Concordia |
| Ingredient: | pilocarpine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020237
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 020237
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SALAGEN | pilocarpine hydrochloride | TABLET;ORAL | 020237 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0228-2801 | 0228-2801-11 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0228-2801-11) |
| SALAGEN | pilocarpine hydrochloride | TABLET;ORAL | 020237 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0228-2837 | 0228-2837-11 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0228-2837-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 22, 1994 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Apr 18, 2003 | TE: | AB | RLD: | Yes | ||||
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