Application 050608

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	Yes	Yes
002	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	Yes	Yes
003	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	No	No
005	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050608-001	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31
N050608-002	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31
N050608-003	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31
N050608-005	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N050608-001	AP
N050608-002	AP
N050608-005	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050608-001	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-002	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1986-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-003	UNASYN	EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION			1986-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-005	UNASYN	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1993-12-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050608-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050608-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050608-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050608-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050608-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050608-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050608-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050608-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050608-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050608-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050608-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050608-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050608-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050608-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050608-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050608-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050608-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050608-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050608-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050608-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050608-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050608-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050608-001	AP	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UNASYN	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Roerig	155c7ec0-5862-404f-b1d0-f278f8a8bbda	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050608 application number: NDA050608 ndc (product): 0049-0013 ndc (product): 0049-0014
UNASYN	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Roerig	12eeb72a-403d-41be-bae4-4cb930862884	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050608 application number: NDA050608 ndc (product): 0049-0024

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0022	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0023	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0024	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0024	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0024	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current
0049-0024	UNASYN	ampicillin sodium and sulbactam sodium	Roerig	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84118	SUPPL	2025-11-06
84088	SUPPL	2025-11-06
81085	SUPPL	2025-02-06
81074	SUPPL	2025-02-06
78376	SUPPL	2024-05-03
78351	SUPPL	2024-05-02
64917	SUPPL	2020-10-14
64896	SUPPL	2020-10-14
57693	ORIG	2019-02-15
53779	SUPPL	2018-04-23
53752	SUPPL	2018-04-20
47247	SUPPL	2017-02-16
47197	SUPPL	2017-02-14
17925	SUPPL	2014-11-20
17924	SUPPL	2014-11-20
30162	SUPPL	2014-11-19
7880	SUPPL	2014-11-19
7879	SUPPL	2012-03-13
39036	SUPPL	2012-03-07
17923	SUPPL	2008-04-23
30161	SUPPL	2008-04-16
30160	SUPPL	2004-08-25
22167	SUPPL	1997-02-12