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Details for New Drug Application (NDA): 050630

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NDA 050630 describes PRIMAXIN, which is a drug marketed by Merck and is included in three NDAs. It is available from two suppliers. Additional details are available on the PRIMAXIN profile page.

The generic ingredient in PRIMAXIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.

Summary for NDA: 050630

cilastatin sodium; imipenem
Therapeutic Class:Antibacterials

Summary for product number 001

Approval Date:Dec 14, 1990TE:RLD:No

Summary for product number 002

Approval Date:Dec 14, 1990TE:RLD:No

Expired Orange Book Patents for NDA: 050630

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
cilastatin sodium; imipenem
POWDER;INTRAMUSCULAR050630-001Dec 14, 19905,147,868<disabled>
cilastatin sodium; imipenem
POWDER;INTRAMUSCULAR050630-002Dec 14, 19905,147,868<disabled>
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