Details for New Drug Application (NDA): 012827

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NDA 012827 describes ROBINUL FORTE, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the ROBINUL FORTE profile page.

The generic ingredient in ROBINUL FORTE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 012827

Tradename:	ROBINUL FORTE
Applicant:	Casper Pharma Llc
Ingredient:	glycopyrrolate
Patents:	0

Pharmacology for NDA: 012827

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 012827

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 012827

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROBINUL	glycopyrrolate	TABLET;ORAL	012827	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-743	16571-743-03	30 TABLET in 1 CONTAINER (16571-743-03)
ROBINUL	glycopyrrolate	TABLET;ORAL	012827	NDA AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-743	16571-743-09	90 TABLET in 1 CONTAINER (16571-743-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AA	RLD:	Yes

Expired US Patents for NDA 012827

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Casper Pharma Llc	ROBINUL	glycopyrrolate	TABLET;ORAL	012827-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Casper Pharma Llc	ROBINUL FORTE	glycopyrrolate	TABLET;ORAL	012827-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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