Details for New Drug Application (NDA): 217052
NDA 217052 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 217052
| Tradename: | PILOCARPINE HYDROCHLORIDE |
| Applicant: | Fdc Ltd |
| Ingredient: | pilocarpine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217052
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 217052
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 217052 | ANDA | Leading Pharma, LLC | 69315-314 | 69315-314-15 | 15 mL in 1 BOTTLE, PLASTIC (69315-314-15) |
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 217052 | ANDA | Leading Pharma, LLC | 69315-315 | 69315-315-15 | 15 mL in 1 BOTTLE, PLASTIC (69315-315-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Oct 2, 2025 | TE: | AT | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 2% | ||||
| Approval Date: | Oct 2, 2025 | TE: | AT | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 4% | ||||
| Approval Date: | Oct 2, 2025 | TE: | AT | RLD: | No | ||||
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