Details for New Drug Application (NDA): 212377
NDA 212377 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Fdc Ltd, Rising, Somerset Theraps Llc, Impax Labs, Innogenix, Lannett Co Inc, Padagis Us, and Quagen, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the PILOCARPINE HYDROCHLORIDE profile page.
The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 212377
| Tradename: | PILOCARPINE HYDROCHLORIDE |
| Applicant: | Quagen |
| Ingredient: | pilocarpine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212377
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 212377
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 212377 | ANDA | Aurobindo Pharma Limited | 59651-224 | 59651-224-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-224-01) |
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 212377 | ANDA | Aurobindo Pharma Limited | 59651-225 | 59651-225-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-225-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 13, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Aug 13, 2019 | TE: | AB | RLD: | No | ||||
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