Application 060677

Type: ANDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOTACILLIN-N	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 125MG BASE/VIAL	No	No
002	TOTACILLIN-N	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No
003	TOTACILLIN-N	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
004	TOTACILLIN-N	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
005	TOTACILLIN-N	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No
006	TOTACILLIN-N	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A060677-001	TOTACILLIN-N	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A060677-002	TOTACILLIN-N	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A060677-003	TOTACILLIN-N	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A060677-004	TOTACILLIN-N	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A060677-005	TOTACILLIN-N	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982
A060677-006	TOTACILLIN-N	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060677-005	TOTACILLIN-N	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060677-006	TOTACILLIN-N	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060677-005	TOTACILLIN-N	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060677-006	TOTACILLIN-N	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060677-005	TOTACILLIN-N	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060677-006	TOTACILLIN-N	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060677-005	TOTACILLIN-N	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060677-006	TOTACILLIN-N	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060677-005	TOTACILLIN-N	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060677-006	TOTACILLIN-N	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060677-005	TOTACILLIN-N	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060677-006	TOTACILLIN-N	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060677-001	TOTACILLIN-N	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060677-002	TOTACILLIN-N	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060677-003	TOTACILLIN-N	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060677-004	TOTACILLIN-N	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMPICILLIN	AMPICILLIN SODIUM	Henry Schein, Inc.	78988f6a-a73b-4d3b-9a76-d61a748c3c16	2026-07-31	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin Sodium	AMPICILLIN SODIUM	Sagent Pharmaceuticals	5b3796dd-6f81-4999-ae2b-a13a72795729	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	NorthStar Rx, LLC	3b683547-48ac-48ca-8fd4-6866fd17be34	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
AMPICILLIN	AMPICILLIN SODIUM	Henry Schein, Inc.	06ca924c-5f3a-4924-90f4-5ba623daaa0e	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin sodium	AMPICILLIN SODIUM	Medical Purchasing Solutions, LLC	402e7cc7-5ae8-c113-e063-6394a90aa54a	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Eugia US LLC	b7bf2897-8272-4c7d-84e9-6fbba0ea63fa	2025-08-14	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Eugia US LLC	66146d45-0fe4-46b9-b2b1-b67c219088b7	2025-08-14	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN	Armas Pharmaceuticals Inc.	34e95c91-3767-493c-8716-38e61e7c6674	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	ProPharma Distribution	364b1db9-e523-7bae-e063-6294a90a651d	2025-07-18	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin sodium	AMPICILLIN	Civica, Inc.	2fd0f9fa-5b86-42f7-9a9f-767123638d39	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	67dd2930-8482-4da5-b663-b751aff18c61	2025-05-16	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	64a04e8c-8f78-46b3-8f45-56ef225a4f74	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Avenacy Inc.	19546563-50b7-4160-8cbe-f8e7079cba69	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Athenex Pharmaceutical Division, LLC.	06b1c203-600c-4083-986a-d1d471b56e43	2025-01-28	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	c2908a44-1da4-4885-ae5a-23f69189d91a	2024-10-31	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	b371e1a5-1fef-4df2-8940-c4fc02b9e2f0	2024-10-31	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	5308ddfa-4a5b-4f7b-83ce-9d1b528e050d	2024-05-09	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	6632a5bd-45f1-422f-80b0-46e5a628969a	2024-05-08	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	Sandoz Inc	f77db491-31c4-4a7c-a114-0f3244c97090	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM
Ampicillin	AMPICILLIN SODIUM	NorthStar Rx, LLC	6772d650-9814-49e4-a4ec-0b1a97b837d1	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: AMPICILLIN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.