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Details for New Drug Application (NDA): 014602

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NDA 014602 describes CELESTONE SOLUSPAN, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from two suppliers. Additional details are available on the CELESTONE SOLUSPAN profile page.

The generic ingredient in CELESTONE SOLUSPAN is betamethasone acetate; betamethasone sodium phosphate. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone acetate; betamethasone sodium phosphate profile page.

Pharmacology for NDA: 014602

Suppliers and Packaging for NDA: 014602

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELESTONE SOLUSPAN
betamethasone acetate; betamethasone sodium phosphate
INJECTABLE;INJECTION 014602 NDA Merck Sharp & Dohme Corp. 0085-0566 0085-0566-05 1 VIAL, MULTI-DOSE in 1 BOX (0085-0566-05) > 5 mL in 1 VIAL, MULTI-DOSE
CELESTONE SOLUSPAN
betamethasone acetate; betamethasone sodium phosphate
INJECTABLE;INJECTION 014602 NDA REMEDYREPACK INC. 49349-757 49349-757-57 5 mL in 1 VIAL, MULTI-DOSE (49349-757-57)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3MG/ML;EQ 3MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 014602

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CELESTONE SOLUSPAN
betamethasone acetate; betamethasone sodium phosphate
INJECTABLE;INJECTION014602-001Approved Prior to Jan 1, 19823,485,854► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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