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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 201820

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NDA 201820 describes BETHKIS, which is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. Additional details are available on the BETHKIS profile page.

The generic ingredient in BETHKIS is tobramycin. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for 201820

Tradename:	BETHKIS
Applicant:	Chiesi
Ingredient:	tobramycin
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 201820

Medical Subject Heading (MeSH) Categories for 201820

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201820

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETHKIS	tobramycin	SOLUTION;INHALATION	201820	NDA	Chiesi USA, Inc.	10122-820	10122-820-04	4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE
BETHKIS	tobramycin	SOLUTION;INHALATION	201820	NDA	Chiesi USA, Inc.	10122-820	10122-820-28	7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	300MG/4ML
Approval Date:	Oct 12, 2012	TE:	AN	RLD:	Yes

Expired US Patents for NDA 201820

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	⤷ Try a Trial	⤷ Try a Trial
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	⤷ Try a Trial	⤷ Try a Trial
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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