Details for New Drug Application (NDA): 214193
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NDA 214193 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Fdc Ltd, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us, 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 are twelve drug master file entries for this compound. Fourteen 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 are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 214193
| Tradename: | PILOCARPINE HYDROCHLORIDE |
| Applicant: | Amneal |
| Ingredient: | pilocarpine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214193
| Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 214193
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 214193 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1745 | 69238-1745-8 | 1 BOTTLE in 1 CARTON (69238-1745-8) / 15 mL in 1 BOTTLE |
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 214193 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1746 | 69238-1746-8 | 1 BOTTLE in 1 CARTON (69238-1746-8) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Sep 21, 2020 | TE: | AT | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 2% | ||||
| Approval Date: | Sep 21, 2020 | TE: | AT | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 4% | ||||
| Approval Date: | Sep 21, 2020 | TE: | AT | RLD: | No | ||||
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