Application 062901

Type: ANDA
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 1GM BASE/VIAL;EQ 500MG BASE/VIAL	No	Yes
002	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062901-001	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23
A062901-002	UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27

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 3 · 82 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	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1988-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1992-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-11-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062901-001	UNASYN	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-11-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062901-002	UNASYN	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1992-02-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062901-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062901-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062901-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062901-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062901-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062901-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062901-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062901-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062901-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062901-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062901-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062901-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062901-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062901-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062901-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062901-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062901-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062901-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062901-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062901-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062901-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062901-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062901-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062901-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062901-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062901-002	AP	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A062901-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062901-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062901-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062901-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062901-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062901-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062901-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062901-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062901-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062901-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062901-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062901-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062901-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062901-002	AP	1	`3bdfa0b2c4d7…`

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	Name fallback brand name: UNASYN
UNASYN	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Roerig	12eeb72a-403d-41be-bae4-4cb930862884	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: UNASYN