Requests that FDA declare that Dicyclomine Hydrochloride Tablets, 10 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

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FDA

FDA-2025-P-7006

Requests that FDA declare that Dicyclomine Hydrochloride Tablets, 10 mg, is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Comment Period OpensDec 12, 2025

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.	May 15, 2026	--

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Dicyclomine Hydrochloride Tablets, 10 mg, is

suitable for submission as an ANDA

the Reference Listed Drug (“RLD”) upon which

this petition is based is