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Orange Book product · Brand (NDA)

SINCALIDE

SINCALIDE

Brand (NDA)NDA 210850TE APRX MAIA PHARMS INC

At a glance

Nov 22, 2022

Approved

Brand (NDA)

Application

AP

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 22, 2022

    3 yr 8 mo ago

  2. Today

  3. Patent 11110063 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  4. Patent 11110063 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  5. Patent 11110063 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  6. Patent 11318100 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  7. Patent 11318100 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  8. Patent 11318100 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  9. Patent 11318100 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  10. Patent 11737983 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

  11. Patent 11737983 expires

    Listed drug product patent expiration.

    Apr 20, 2038

    in 12 yr

Pharmaceutical detail

Active ingredient

SINCALIDE

Strength

0.005MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

AP

Application

NDA 210850

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11110063Apr 20, 2038in 12 yr
ProductU-3481
11110063Apr 20, 2038in 12 yr
ProductU-3482
11110063Apr 20, 2038in 12 yr
ProductU-3483
11318100Apr 20, 2038in 12 yr
ProductU-3477
11318100Apr 20, 2038in 12 yr
ProductU-3478
11318100Apr 20, 2038in 12 yr
ProductU-3479
11318100Apr 20, 2038in 12 yr
ProductU-3480
11737983Apr 20, 2038in 12 yr
ProductU-3482
11737983Apr 20, 2038in 12 yr
ProductU-3689
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