Application 060075

Type: ANDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PFIZERPEN G	PENICILLIN G POTASSIUM	TABLET;ORAL	50,000 UNITS	No	No
002	PFIZERPEN G	PENICILLIN G POTASSIUM	TABLET;ORAL	100,000 UNITS	No	No
003	PFIZERPEN G	PENICILLIN G POTASSIUM	TABLET;ORAL	200,000 UNITS	No	No
004	PFIZERPEN G	PENICILLIN G POTASSIUM	TABLET;ORAL	250,000 UNITS	No	No
005	PFIZERPEN G	PENICILLIN G POTASSIUM	TABLET;ORAL	400,000 UNITS	No	No
006	PFIZERPEN G	PENICILLIN G POTASSIUM	TABLET;ORAL	800,000 UNITS	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
A060075-001	PFIZERPEN G	PENICILLIN G POTASSIUM	50,000 UNITS	TABLET / ORAL	Approved before 1982
A060075-002	PFIZERPEN G	PENICILLIN G POTASSIUM	100,000 UNITS	TABLET / ORAL	Approved before 1982
A060075-003	PFIZERPEN G	PENICILLIN G POTASSIUM	200,000 UNITS	TABLET / ORAL	Approved before 1982
A060075-004	PFIZERPEN G	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982
A060075-005	PFIZERPEN G	PENICILLIN G POTASSIUM	400,000 UNITS	TABLET / ORAL	Approved before 1982
A060075-006	PFIZERPEN G	PENICILLIN G POTASSIUM	800,000 UNITS	TABLET / ORAL	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	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060075-005	PFIZERPEN G	400,000 UNITS	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060075-006	PFIZERPEN G	800,000 UNITS	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060075-005	PFIZERPEN G	400,000 UNITS	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060075-006	PFIZERPEN G	800,000 UNITS	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060075-005	PFIZERPEN G	400,000 UNITS	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060075-006	PFIZERPEN G	800,000 UNITS	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060075-005	PFIZERPEN G	400,000 UNITS	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060075-006	PFIZERPEN G	800,000 UNITS	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060075-005	PFIZERPEN G	400,000 UNITS	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060075-006	PFIZERPEN G	800,000 UNITS	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060075-005	PFIZERPEN G	400,000 UNITS	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060075-006	PFIZERPEN G	800,000 UNITS	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060075-001	PFIZERPEN G	50,000 UNITS	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060075-002	PFIZERPEN G	100,000 UNITS	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060075-003	PFIZERPEN G	200,000 UNITS	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060075-004	PFIZERPEN G	250,000 UNITS	TABLET / ORAL	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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	56ab659e-ad28-028f-e063-6394a90a6943	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	50c7500f-be06-01af-e063-6294a90a0135	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	efef4846-9497-41af-8dd6-518f86eca7f2	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Avenacy Inc.	969a421e-37d8-499e-9e89-67e210bd5d9d	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Athenex Pharmaceutical Division, LLC.	1442486a-05d6-4dce-8b95-857a30f478c2	2025-01-28	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	2f7ea103-56cc-492f-b862-af45f9aed980	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	d8aaefb6-3f7d-4bc5-b40a-1c58c3054320	2024-12-10	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sagent Pharmaceuticals	fb2f3afe-0072-4383-bad8-9da9e94db4f2	2024-12-04	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	NorthStar Rx, LLC	8732b7ff-2e47-4f99-aadf-81861b431f4f	2024-06-28	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sandoz Inc	91950983-4884-40d1-abd8-bcc953d61b7f	2020-09-16	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM

Reported adverse events (FAERS/openFDA)#

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