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Details for New Drug Application (NDA): 019434

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NDA 019434 describes TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for NDA: 019434

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 6MG BASE/ML
Approval Date:Oct 31, 1985TE:RLD:No

Expired Orange Book Patents for NDA: 019434

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
cimetidine hydrochloride
INJECTABLE;INJECTION019434-001Oct 31, 19853,950,333► subscribe
Glaxosmithkline
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
cimetidine hydrochloride
INJECTABLE;INJECTION019434-001Oct 31, 19854,024,271► subscribe
Glaxosmithkline
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
cimetidine hydrochloride
INJECTABLE;INJECTION019434-001Oct 31, 19853,950,933► subscribe
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