Details for New Drug Application (NDA): 212377
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NDA 212377 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us, and is included in eight NDAs. It is available from nine 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 212377
| Tradename: | PILOCARPINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| 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 | NorthStar Rx LLC | 16714-121 | 16714-121-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-121-01) |
| PILOCARPINE HYDROCHLORIDE | pilocarpine hydrochloride | TABLET;ORAL | 212377 | ANDA | NorthStar Rx LLC | 16714-122 | 16714-122-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-122-01) |
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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