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SAIZEN

BLA

SOMATROPIN | B019764 | EMD SERONO

4 products0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 19764 | 4 presentations

351(a) ReferenceVoluntarily RevokedCDERFor Injection

Proper Name

somatropin

Applicant

EMD Serono, Inc.

Approval Date

8-Oct-96

Presentations

6MG — Single-Dose Vial (Subcutaneous)

5MG — Single-Dose Vial (Subcutaneous)

8.8MG — Single-Dose Vial (Subcutaneous)

4MG — Single-Dose Vial (Subcutaneous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Mar 5, 2021	SUPPL -86	View Letter (PDF)
Mar 23, 2020	SUPPL -25	View Letter (PDF)
Mar 23, 2020	SUPPL -39	View Letter (PDF)
Mar 23, 2020	SUPPL -72	View Letter (PDF)
Mar 23, 2020	SUPPL -20	View Letter (PDF)
Mar 23, 2020	SUPPL -30	View Letter (PDF)
Mar 23, 2020	SUPPL -23	View Letter (PDF)
Mar 23, 2020	SUPPL -35	View Letter (PDF)
Mar 23, 2020	SUPPL -37	View Letter (PDF)
Mar 23, 2020	SUPPL -49	View Letter (PDF)
Mar 23, 2020	SUPPL -83	View Letter (PDF)
Mar 23, 2020	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 6MG/VIAL

▴

INJECTABLE;INJECTION | Approved: 1996-10-08 00:00:00

No patent or exclusivity listings for this strength.

#002 — 5MG/VIAL

▾

INJECTABLE;INJECTION | Approved: 1996-10-08 00:00:00

#003 — 8.8MG/VIAL

▾

INJECTABLE;INJECTION | Approved: 1996-10-08 00:00:00

#005 — 4MG/VIAL

▾

INJECTABLE;INJECTION | Approved: 1996-10-08 00:00:00