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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020648

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DIASTAT (DIAZEPAM)
2.5MG/0.5ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 2.5MG/0.5ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020648
Product Number: 001
Approval Date: Jul 29, 1997
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DIASTAT ACUDIAL (DIAZEPAM)
10MG/2ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT ACUDIAL
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020648
Product Number: 007
Approval Date: Sep 15, 2005
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DIASTAT ACUDIAL (DIAZEPAM)
20MG/4ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT ACUDIAL
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 20MG/4ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020648
Product Number: 006
Approval Date: Sep 15, 2005
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DIASTAT (DIAZEPAM)
5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020648
Product Number: 002
Approval Date: Jul 29, 1997
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DIASTAT (DIAZEPAM)
10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020648
Product Number: 003
Approval Date: Jul 29, 1997
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DIASTAT (DIAZEPAM)
15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020648
Product Number: 004
Approval Date: Jul 29, 1997
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DIASTAT (DIAZEPAM)
20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DIAZEPAM
Proprietary Name: DIASTAT
Dosage Form; Route of Administration: GEL; RECTAL
Strength: 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020648
Product Number: 005
Approval Date: Jul 29, 1997
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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